chrisvoncsefalvay/vaers-outcomes huggingface dataset:
papular rash on back of both hands (3 - 4 papules each hand).  First noticed morning of 3/30/03.  2 additional papules noticed 4/4/03.  No systemic symptoms
Sore arm; Intentional administration of vaccine to patient <18 yrs of age; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and OFF LABEL USE (Intentional administration of vaccine to patient <18 yrs of age) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02b21a and 043b21a) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and OFF LABEL USE (Intentional administration of vaccine to patient <18 yrs of age). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown and OFF LABEL USE (Intentional administration of vaccine to patient <18 yrs of age) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided. Patient race is black.   This case was linked to MOD-2021-067524, MOD-2021-221042, MOD-2021-257236 (Patient Link).
Moderate to strong tinnitus, onset within 2 hours and continuing, 4 days since vaccine. Multiple pitches heard at once, in the high range, unchanging other than loudness.  Each vaccine has given me this same tinnitus. Last vaccine was 11/2021, the tinnitus had faded over the last couple of months to barely noticeable.
Initial and follow up information has been received from a medical assistant concerning a patient of unknown age and gender. On 17-APR-2015 the patient was vaccinated with GARDASIL lot # K006960 (expiration date, dose, route and site of administration were not reported) that was exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information is not expected as all follow ups requested to complete the case were received.
Developed shingles; Right chest wall involvement with post herpetic neuralgia; This is a spontaneous report from a contactable physician, the patient. A 54-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EK9231) via an unspecified route of administration in the left arm on 29Dec2020 at 19:00 (at the age of 54-years-old) as single dose for COVID-19 immunisation. The patients' medical history included HTN (hypertension), GERD (gastroesophageal reflux disease) and seasonal allergies. The patient had no known drug allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the COVID-19 vaccination. On 27Mar2021, the patient developed shingles. The patient reported that it was a moderate case. On 27Mar2021, the patient also experienced right chest wall involvement with post herpetic neuralgia. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with valacyclovir (VALTREX) 1000 mg TID (three times a day) for 7 days. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of shingles and right chest wall involvement with post herpetic neuralgia were resolved with lasting effects on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
1 - Mild irritation on arm at location of vaccine injection. Red and itchy. Lasted for 4 months starting 1 hour after injection. 2 - Potential (not confirmed) relation to vaccine. Couple of months after injection, I developed plantar fasciitis. Prior to the vaccine, I did not have this condition. This issue is still present. 3 - Potential (not confirmed) relation to vaccine. Few of months after injection, I developed 'tennis elbow'. Prior to the vaccine, I did not have this condition. This issue is still present. ALL - The 3 above items involve inflammation.
Extreme pain and swelling in both feet, hands and left knee, to extent that I was unable to walk for two weeks. Treated with Prednisone for two weeks. Had immediate relapse, so then treated with Prednisone for one week. Another immediate relapse, so treated with Prednisone again for two weeks. Now off Prednisone, no swelling, but taking Meloxicam oral tabs for joint and muscle pain.
5 MIN AFTER GETTING VARICELLA VACCINE SAID HIS THROAT HURT, COUGHING, ITCHING.  IMMEDIATELY GIVEN ALBUTEROL, BENEDRYL AND DECADRON. DEVELOPED HIVES WIDE SPREAD. PT TRANSPORTED TO ED FOR OBSERVATION.  SENT HOME IN GOOD CONDITION.
Left side neck, shoulder, arm pain 10 of 10 on 0-10 pain scale, redness and swelling to site.
No Adverse event; 10 patients have received a bivalent Moderna COVID-19 vaccine after the 30 day BUD from 13 DEC 2022-17 DEC 2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (10 patients have received a bivalent Moderna COVID-19 vaccine after the 30 day BUD from 13 DEC 2022-17 DEC 2022) and NO ADVERSE EVENT (No Adverse event) in an adult 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. 024H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2022, 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. In December 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (10 patients have received a bivalent Moderna COVID-19 vaccine after the 30 day BUD from 13 DEC 2022-17 DEC 2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (10 patients have received a bivalent Moderna COVID-19 vaccine after the 30 day BUD from 13 DEC 2022-17 DEC 2022) 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 (10 patients have received a bivalent Moderna COVID-19 vaccine after the 30 day BUD from 13 DEC 2022-17 DEC 2022).    No Concomitant medications were provided.  It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Caller reported that beyond use date was on 12 Dec 2022 but they discovered it on 17 Dec 2022 and 10 patients have received a bivalent Moderna COVID-19 vaccine after the 30 day BUD from 13 DEC 2022-17 DEC 2022.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Dec-2022: Live Follow-up received included suspect product information batch/lot number, patient information and narrative comments.
Received 1st Pfizer dose on 12/18/20, received 2nd dose of Pfizer on 1/6/21. Tested positive for COVID 2/3/21, asymptomatic following high risk exposure on 1/29/21.
pt recv vax & grandma reported pt c/o having swelling in rt arm, hives on back;DPH given w/relief;
parents state pt devel t102-104.7 evening;temp lasted 2 days & left;temp returned 5 days later lasting 5 days;talked w/MD who stated poss viral infect;to see MD today
2JUN95 fever 103;ear infect;viral sore throat;amoxicillin for ear infect;11JUN95 fever 105, ear infect;
crying & irritable x 3 days;t100R;no swelling @ inj site;spitting up more than usual;
COVID; This case was reported by a pharmacist and described the occurrence of coronavirus infection in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th September 2020, the patient received the 1st dose of Shingrix. In September 2020, less than a week after receiving Shingrix, the patient experienced coronavirus infection. The patient was treated with monoclonal antibody (nos) (Monoclonal Antibody). On an unknown date, the outcome of the coronavirus infection was recovered/resolved.   It was unknown if the reporter considered the coronavirus infection to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and developed COVID. The patient received monoclonal antibody treatment and the COVID infection has resolved. The reporter consented to follow up. The HCP did not had the exact date of the COVID diagnosis and did not had the lot and expiry.
have a friend who's daughter is positive, she is on day 8 and doing great; This is a spontaneous report from a contactable consumer or other non hcp.    A female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant was not reported. It was Reported that, The patient experienced have a friend whose daughter is positive; she is on day 8 and doing great on 2021 with outcome of recovering.    The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.
soreness & aching in her arm of injection site; arm and muscle is sore; 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). The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administration date 30Apr2021 (Batch/Lot number: unknown) at the age of 63 years 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: VACCINATION SITE PAIN (non-serious) with onset 30Apr2021, outcome "unknown", described as "soreness & aching in her arm of injection site"; MYALGIA (non-serious) with onset 30Apr2021, outcome "unknown", described as "arm and muscle is sore".  Additional Information: It was reported that patient got her first dose on 30APR2021 and scheduled to get the second dose on 21May. She experienced arm and muscle was sore on the injection site. She wanted to know if she can use Salonpas with Lidocaine. She mentioned that its not an adverse reaction and that its just a little muscle sore.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After 13 days I was found to have high blood pressure. I  always have normal blood pressure. I had doctors visit 09/02/2022. BP was 120/64. I  received vaccine on 09/13/2022. Next BP check was on 09/26/2022 and was 140/94. Since then the am checking BP quite often and is 130-150/85-90. No symptoms. There's no charge in my diet, no weight gain, I exercise 60-90 minutes regularly. No stress. Can't explain any other factors for high BP.  So I believe covid booster could be responsible. I am a cardiologist. I don't have any symptoms. I have not started any BP medicine. I found a study regarding high BP after covid vaccine. I was wondering will this be permanent or temporary? Any suggestions/recommendation?
within 24 hrs after vaccination, arm became red, swollen, and painful. admitted to hospital 48 hrs after vaccine receive, and treated for cellulitis of arm. 6/8/09 MR received for DOS 5/13-15/2009 with D/C DX;  Cellulitis; right upper arm.. HTN-good control.  S/P small intestine resection due to ruptured diverticulum with peritonitis-improved. Diverticulosis. Pt presented back to hospital after recent surgery with c/o sore and inflamed R upper arm.  T=100.6'F. Dx with cellulitis and admitted for IV abx which improved.
covid vaccine breakthrough case  dose 1 Pfizer 1/27/21 EL0142 dose 2 Pfizer 2/18/21 EM9810
Initial unsolicited report received from the literature on 29 July 2016. This case is linked to 2016SA140361, 2016SA140381, 2016SA140455, 2016SA140480, 2016SA140494, 2016SA140962, 2016SA140980, 2016SA140990, 2016SA141005, 2016SA141097, 2016SA141105 (same literature). The following is verbatim from the article: Abstract: Background: No comparative review of Vaccine Adverse Event Reporting System (VAERS) submissions following pandemic influenza A (H1N1) 2009 and seasonal influenza vaccinations during the pandemic season has been published. Methods: We compared two populations' adverse event reporting rates. Adverse events (AEs) following vaccination were identified from VAERS for adults aged 17-44 years after pandemic (monovalent influenza [MIV], and seasonal (trivalent inactivated influenza [IIV3], live attenuated influenza [LAIV3]) vaccines. Results: Vaccination coverage was more than four times higher for MIV and more than twenty times higher for LAIV3 in the first population than in the second population. The reporting rate of serious AE reports following MIV in the first population (1.19 per 100,000) was about half that reported by the second population (2.45 per 100,000). Conversely, the rate of serious AE reports following LAIV3 among the first population (1.32 per 100,000) was more than twice that of the second population. Although fewer first population AEs following MIV were reported overall, the rate of Guillain-Barre Syndrome (GBS) (4.01 per million) was four times greater than that in the second population. (1.04 per million). Conclusions: Despite higher vaccination coverage in the first population, the rate of serious AEs following MIV was about half that in the second population. The rate of GBS reported following MIV was higher in the first population. This case involves an 18 year old male patient who was vaccinated with a dose of H1N1 Vaccine (manufacturer: unknown, batch number, expiry date, route and site of administration: not reported) on an unspecified date. The patient's medical history included migraine, depression and penicillin (PCN) allergy. Concomitant medications were not reported. On an unspecified date, 97 days post vaccination, patient experienced paresthesia and numbness in upper and lower limbs, areflexia and photophobia. Patient was diagnosed with Guillain-Barre syndrome (neurologist's Diagnosis). Lab data included: cerebrospinal fluid which showed positive albumin cytologic dissociation. Patient received corrective treatment with Plasmapheresis IVIG. Outcome of events was not reported. Upon internal review, the company decided to consider the event as serious because of important medical event: Guillain-Barre syndrome. Documents held by sender: none. Sender's Comments: This case refers to a patient who received H1N1 VACCINE and 97 days later experienced Guillain-Barre syndrome. The product manufacturer is unknown. Very limited information is provided in this case, however, considering the time to onset of 97 days, the role of the vaccine seems to be unlikely.
Information has been received through the Merck pregnancy registry from a registered nurse concerning an 18 year old female who on 02-JUL-2007 was vaccinated with the first dose of GARDASIL (655205/1426F).  On 24-SEP-2007 the patient was vaccinated with the second dose of GARDASIL (657617/0384U).  The patient was seen in the emergency room on approximately 27-NOV-2007 with stomach aches and had a positive blood pregnancy test (LMP = 14-OCT-2007).  On 04-DEC-2007 the patient was seen in the physician's office and had a positive urine pregnancy test.  Concomitant therapy included pre-natal vitamins + Vitamin C.  On 28-FEB-2008, the patient had an amnio test done, and the results were within normal limits.  On approximately 17-MAR-2008, the patient experienced urinary tract infection and was treated with MACROBID, 100mg, BID during 5 days.  On 21-JUL-2008, at 40 weeks from LMP, the patient had a male liveborn infant normal who weighed 7lbs 5 ounces, length 21.5 inches, and had a head circumference of 14 inches.  There were no complications, infections or illnesses during the pregnancy or the labor/delivery.  The registered nurse reported that the patient had heavy bleeding post partum and required transfusion x 2.  The patient sought medical attention.  Upon internal review heavy bleeding post partum requiring blood transfusions x 2 was determined to be an other important medical event.  No further information is available.
Information has been received from a woman in a medical office concerning a female patient with a "non contributory" medical history who on Dec 5, 2002 was vaccinated in the left deltoid with a first dose of pneumococcal vaccine 23 polyvalent  (lot#644106/0819). Concomitant therapy included lansprazole (Prevacid), estrogens,conjugated (Premarin) and verapamil HCl (Verelan). There was no illness at the time of vaccination. On Dec 5,2002 the patient experienced a "red, hot, swollen, painful lef tupper arm." Medical attention was sought at the doctor's office antibiotics were given. The patient recovered on Dec 09, 2002. No further information is expected.
Patient claims that her arm was swollen after the shot, but 24 hours later the symptoms were red, swollen, painful, puffy, and tender. Her first shot back in April 2019, she only experienced a swollen arm but not to the level of these symptoms.
On  January 8,  I started having a cramping feeling in my right calf. It went on throughout the day without a event.   I woke up the next morning, and the crap was worse. I ran some errands and came home and then looked at my calf of my leg and it was twice the size as my other leg. I had four spots of bruising from ankle to knee. I immediately went to the emergency room.    I was hospitalized and had bloodwork and an MRI done which showed that I had a DVT and a pulmonary embolus in my right lung. I was hospitalized for two days on blood thinners. I had no shortness of breath or heart problems during this time. I was then released from the hospital on blood thinners which I have to take for the next six months.
PATIENT HAD PRE DEPLOYMENT HCG DRAWN AND WAS FOUND TO HAVE BEEN PREGNANT.
Vaccinate and the next day had trouble raising arm.  Continued to worsen. A week could not raise arm above shoulder.  Range of motion did improve, Still experiencing pain and difficulty sleeping on that side.  MRI done. Told to take 600 mg Motrin every 8 hours and heat applied.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2008, the patient was inoculated with ZOSTAVAX for routine adult health maintenance for the prevention of shingles (strength, route, dosage schedule, and lot number were not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2014, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster. On unspecified dates, as a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient suffered (emotional distress) and would continue suffering significant medical expenses, pain, suffering (emotional distress) and other damages (injury). The final outcome of the events was not specified and were considered to be related to ZOSTAVAX.
No additional AE reported; a patient was administered VARIVAX after a temperature excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, and concurrent conditions were not reported. Concomitant therapies were not reported.  On 19-JAN-2022, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot #U019904, expiration date: 24-JUN-2023, administered for prophylaxis (strength, anatomical location and route of administration were not provided) which was administered after temperature excursion of 12.4 Fahrenheit (°F) during a time frame of 0 hours, 20 minutes and 0 seconds. Previous temperature excursion of 6°F to 14°F (11.6F) for 0 hours 25 minutes and 0 seconds  No additional additional adverse events were reported.
Onset fever of 104 an evening of vax; dx w/beta strep group B bacteremia-sepsis; DTP reaction r/o;
Information has been received from a physician concerning a child who was vaccinated with VARIVAX (Oka/Merck).  Subsequently the patient developed herpes ZOSTER.  A ZOSTER specimen confirmed recombination of vaccine strain and wild type VARICELLA ZOSTER virus in this patient.  This is one of several reports from the same source.
15-20 min after vaccination pt complained of nausea; taken into private clinic room; then felt dizzy and chilly. VS 128/100 P90 radial. Lay flat for dizziness on right side. Pt alert, talking; began to complain of tightness in chest, then moving to throat. Nurse administered epinephrine; Called director of pt services when stable.
1. Headache began with 10 minutes and has lasted every day since March 9th, sometimes requiring multiple doses of Tylenol or injections of Toradol at night to relive severe pain. Today is April 5th and the headaches still persist. The headaches usually felt like a power drill going through both temples. I am NOT headache prone. Other headaches radiated from my shoulders up over my head and down the other side of my head.  My shoulders and upper back ached and still does as of today. 2. Sinuses blocked within 20 minutes. Regular allergy drainage due to allergies has intensified and has not been controlled by Zyrtec or any other allergy medication. 3. The upper soft pallet in my mouth was swelled and sore for more than 2 weeks. it often bled when I swallowed. 4. I have frequent nosebleeds and sinus pressure. 5,  The fatigue is CRUSHING. It is sometimes so horrid that I cannot do anything and this is unacceptable because I am an online professor and work full time +. I cannot afford not to work!! 6. I had nearly 2 weeks of spiking fevers of about 99-100. The fever spikes would last between 5 and 10 minutes. I know these were not "hot flashes" because I am long past that and am on controlled HRT. 7. The newest side effect is frequent brain fog. This has started in the past 10 days and is very disconcerting and is probably related to the excessive fatigue.  I have spoken with a nurse in my doctor's office and she stated that nobody else she has spoken to has had any of these side effects. I just keep moving on and hope these do not get worse with the second shot,   As of today, April 5th, these
8OCT92 devel cold sx-stuffy nose, body aches, fever, small red rash on face, neck, ears-gradual swelling of eyes, ears, face; ER visit 12OCT92;
High fever - <101 degrees  (more than 24 hours), swelling and redness at vaccination site (for 1 week), no appetite for 2 days.  Treatment aspirin
Started with chills and a fever, woke up at 3am with temp of 101.3 took 500mg Tylenol. Experiencing dizziness, body aches, and sharp pain in right rib cage. At 10am, temp was elevated. Continuation of previous symptoms, took another 500mg Tylenol. Current temp of 101.8 with GI upset.