chrisvoncsefalvay/vaers-outcomes huggingface dataset:
p/vax pt devel inj site rxn by warmth; soreness & 3-4 cm area of redness; also devel axillary supraclavicular lymphadenopathy tx w/ATB w/o much response;
Patient received first dose of Rabavert on 13-Mar-2023 and no further doses until now; Case reference number US-BN-2023-000807 is a spontaneous case report initially received on 08-May-2023 from a nurse (reference number: USBAV23-0620) and concerns a female patient in her 20's.  The patient's relevant medical history and concomitant medication details were not provided.  On 13-Mar-2023, the patient was vaccinated with the first dose of RabAvert vaccine (batch number not provided) at unknown dose, at an unknown route or site of administration, for pre-exposure for rabies. Patient was scheduled for second dose of RabAvert vaccine on day 7 from first dose, but no further doses were received after the first dose (explicitly coded as 'Incomplete course of vaccination').   At the time of this initial report, it was unknown if the patient experienced any adverse event due to RabAvert vaccine.  Additional information received from Bavarian Nordic on 09-May-2023 included local ID.; Reporter's Comments: A female patient in her 20's was vaccinated with the first dose of RabAvert vaccine for pre-exposure for rabies. Patient was scheduled for second dose of RabAvert vaccine on day 7 from first dose, but no further doses were received after the first dose, which is considered as incomplete course of vaccination. No associated adverse events were reported. Incomplete course of vaccination is listed per company convention. The patient's relevant medical history and concomitant medication details were not provided. Incomplete course of vaccination is not related to RabAvert, but to a human factor. The case is non-serious.; Sender's Comments: A female patient in her 20's was vaccinated with the first dose of RabAvert vaccine for pre-exposure for rabies. Patient was scheduled for second dose of RabAvert vaccine on day 7 from first dose, but no further doses were received after the first dose, which is considered as incomplete course of vaccination. No associated adverse events were reported. Incomplete course of vaccination is listed per company convention. The patient's relevant medical history and concomitant medication details were not provided. Incomplete course of vaccination is not related to RabAvert, but to a human factor. The case is non-serious.
On 9/14/21, The patient received Moderna 0.5ml via Left deltoid at 2:45 PM.   At 2:50 pm patient C/O itchy throat, swelling, numbness, and tingling of left upper and lower extremities, swelling of left lips and ear. 911 called at 2:52 pm. Patient alert and oriented. Vital taken and the patient was monitored until EMT arrival around 2:58 pm. B/P=150/96, P=112, R=20.    The patient consented to transport to the nearest hospital and her husband accompanied.
A few minutes after received my second shot, I started getting dizzy, shortness of breath, breath very fast,, chest pain, my heart was pounding very fast. Hands and legs were cramped up. For a moment, I was not able to response to others. The nurse recorded VS BP 136/85, resp 38, SPO2 100%, pulse 166. The symptoms and signs lasted for about 1 hour and went away.
low grade fevers;muscle aches;joint aches;vision daylight sensitivity-pressure itchy;back pain;fatigue;mysterious rashes & tingling;h/a,chronic fatigue;colds & flu/noc sweats;depression, mental regression inability concentrate -2 yrs almost
Patient started having VERY frequent, VERY runny VERY green mucousy stools.  This diarrhea and generally tired & grouchy baby continued for over two weeks.  Exclusively breast fed baby had always had mustard opaque stools before the vaccine.  Stools eventually returned to mustard & opaque (not slimy) after about 18 days.
Patient experienced mild trouble in swallowing.  She started getting better herself but took some over the counter Diphenhydramine.
On 12/10/22 I noticed a itchy rash on the right side of my abdomen and then once it got more severe it was all over my body with patches on my body with swelling on my hands and feet and it was painful, and I also had chills.  I would say that the rash lasted 2 weeks.  I also had a cold starting Christmas Eve on 12/24/21 and so did my family.  I didn't see a doctor at the time I seen him after the Omicron risk was over.   I can still get a rash if I gently touch my skin but when I seen the doctor I didn't have a rash at the time.  No medication was prescribed by the physician but I did take Benadryl and cream to the rash.
Severe dizziness within 2 or 3 minutes.  All of my allergy symptoms flared up for 2 days after vaccine.
pt recv vax 19MAY97 & pt exp varicella outbreak & was seen by MD who dx approx 12 lesions;no fever was note;It was reported that 2 other pt had a similar exp p/vax WAES9710568 & 97102090;
Pruritus aggravated/ excessive itching all over body; Allergic cough/ cough from allergies; Back pain; Wrist pain; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (Pruritus aggravated/ excessive itching all over body), ALLERGIC COUGH (Allergic cough/ cough from allergies), BACK PAIN (Back pain) and ARTHRALGIA (Wrist pain) in an elderly male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe).   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced PRURITUS (Pruritus aggravated/ excessive itching all over body), ALLERGIC COUGH (Allergic cough/ cough from allergies), BACK PAIN (Back pain) and ARTHRALGIA (Wrist pain). At the time of the report, PRURITUS (Pruritus aggravated/ excessive itching all over body) had resolved and ALLERGIC COUGH (Allergic cough/ cough from allergies), BACK PAIN (Back pain) and ARTHRALGIA (Wrist pain) was resolving.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter causality for the events of cough from allergies, excessive itching all over body, back pain and wrist pain with Humira (adalimumab) was no reasonable possibility.   No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Shingles, arms, legs, and fingers swell. was told he had a Pinched nerve. Patient says that this is bc of the vaccine.
In about six hours after injection, strong pain at injection site. Very tender. At evening time, achiness started and difficult to sleep with pain in arm radiating from injection site. By morning of next day, serious general muscle aches over entire body. Strong headache emanating from back of head and neck out to shoulders. General tiredness and muscle weakness. Unable to perform day's activities. Blood sugar spiked throughout day, even without eating. (Most likely from cortisol being stimulated from oxidative stress of strong muscle ache). Adverse events started to taper off morning of second day. Took 4- 80 mg aspirin which cleared up headache by nightfall. By evening of second day, felt normal.
Itchy hands; red, itchy, puffy hands; red, itchy, puffy hands; This spontaneous report was received from a registered nurse referring to a 36 year old female patient. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies or concurrent conditions. Concomitant therapies included diphenhydramine hydrochloride (BENADRYL).     On 03-FEB-2021, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, route of administration, lot number and expiration date were not reported).     On 04-FEB-2021 at 3:00 upon awakening, the patient experienced red, itchy, puffy hands (pruritus, peripheral swelling and erythema). Following event time, patient was administered diphenhydramine hydrochloride (BENADRYL) as treatment and at that time, only pruritus had resolved on an unspecified date in 2021; patient's hands had remained red and puffy "for a couple of days" and then, after few days, on an unspecified date in 2021, peripheral swelling and erythema also resolved.   Patient's next hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) dose was scheduled for 05-APR-2021, as confirmed by Nurse at call time.       The causality assessment between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the events was unknown.
arm  sore; fatigue; muscle aches; redness at injection site; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE).   On 11th September 2019, the patient received the 1st dose of Shingrix. On 11th September 2019, 7 hrs after receiving Shingrix, the patient experienced pain in arm, fatigue, muscle pain and injection site erythema. On an unknown date, the outcome of the pain in arm, fatigue, muscle pain and injection site erythema were unknown.   It was unknown if the reporter considered the pain in arm, fatigue, muscle pain and injection site erythema to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in unknown arm. About 7 hours later, the patient experienced a sore arm, fatigue, muscle aches and redness at the injection site.  The redness at the site was described as about 3 inches in diameter.  The patient did receive an unspecified pneumonia shot in the opposite arm at the same time as Shingrix. The reporter did not consent to follow up.
Hx of Broken foot in January 2022 however I was seeing a podiatrist. And the injury was healed before the symptoms began to show in 03/2022. Both of my feet have significant numbness and pain, no swelling, and it isn't moving up my legs and it makes it very challenging to walk. It's constant every minute of every day. I had started physical therapy and did not see any improvements at all and did make a an appointment with my GP, due to unknown origin in regards to symptoms. Blood work that I received recently had no abnormalities. I did get a referral for a nerve test sometime in July. I also received Hep A February 10th 2022, chicken pox, and flu vaccine.
This spontaneous report was received from a licensed vocational nurse refers to 3 patients of unknown age and gender. The patients medical history, drug reactions or allergies and concurrent conditions were not reported. On 04-AUG-2015 the patients were administered with a dose of an improperly stored VARIVAX (Merck), lot number K021486, expiry date 03-NOV-2016, (dose and route were not reported). No concomitant medications were reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
This spontaneous report was received from a pharmacist via a company representative refers to a 56 year old female patient. It was reported that on an unspecified date the patient had experienced a prior case of shingles, before the vaccination. On 13-JUN-2014 the patient was vaccinated with ZOSTAVAX, subcutaneous injection, (frequency reported as 1 single shot) for the prevention of shingles (strength, dose and lot number were not reported). No concomitant medications were reported. It was reported that on an unspecified date after receiving ZOSTAVAX, approximately on an unknown date in June 2014, the patient experienced swelling of arm and red pimpled marks on the injection site. The patient had sought medical attention. There was no product quality complaint (PQC) involved. The outcome of swelling of the ram and red pimpled marks on the injection site was reported as recovering. Causality of the event was not provided. Additional information has been requested.
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 33-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), DOXYLAMINE SUCCINATE (UNISOM [DOXYLAMINE SUCCINATE]) and DOCUSATE SODIUM (STOOL SOFTENER) for an unknown indication.    On 18-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 10-Apr-2021. On 18-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 18-Mar-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. Not Provided      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.   Concomitant product use was not provided by the reporter. Treatment information was not provided.
Pt received vaccine at approximately 5:35 pm. A few minutes after patient received vaccine, pt stood up to leave and describes feeling a strong head pain and pressure, and nausea. pt then sat down again in a bench seat next to his brother looking pale out of it. He became very pale and was instructed to elevate his feet. His father felt his head and he was sweaty. While pt was pale in the face and lips, his hands become red and flushed. 911 was called and pt remained pale for several minutes until paramedics arrived at 5:50pm. Vitals per paramedics were: pulse 57 and sitting blood pressure of 120/80; standing blood pressure of 118/72. Patient's father declined transporting to the hospital and patient did regain color. Patient seemed to feel better and was able to get up and walk out of the store. At 7:00pm the patient's parents were called to check on how he was doing. They reported that he seemed to be feeling much better. He had regained his color and was doing his homework and was able to eat dinner.
redness, swelling 3/4 around lt thigh;no fever, tenderness, change in activity;
Information has been received from a 73 year old female patient with CODEINE allergy, who on 09-OCT-2008 was vaccinated with 0.65 ml dose of ZOSTER vaccine. Concomitant therapy included blood pressure medication. On approximately 13-NOV-2008, "about 5 weeks after receiving" the vaccine, the patient had experienced severe pain on the upper right side of her hip however no rash had developed at that time. She had gone to the Emergency Room where she had prescribed acyclovir and PREDNISONE only if rash occurred. On an unspecified date, the patient had routine labs. At time of reporting, the patient had not recovered. Additional information has been requested.
Swollen, red arm for 4 days. Fever of 101-102 degrees for 3 days with around the clock tylenol/ibuprofen.
TESTED  + FOR COVID ON      6-9-22                              ;DECEASED 6-12-22  ; I HAVE NO RECORDS ON THIS PATIENT
She had reportedly received a Johnson and Johnson (Janssen) COVID-19 vaccine on 05/14/2021 and had essentially never been well since. The following week, she was diagnosed with pneumonia (thought to possibly be COVID-related due to ?ground-glass? appearance of lungs on radiologic exam); however, a follow-up COVID-19 test was negative. She was treated with short-term steroids and antibiotics.
Extreme dizziness and nausea on 3/6/21, is getting progressively better little by little.
This case was reported by a consumer via call center representative and described the occurrence of injection site urticaria in a 79-year-old male patient who received SHINGRIX for prophylaxis. On 6th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 6th November 2018, less than a day after receiving SHINGRIX, the patient experienced injection site urticaria, generalized urticaria and muscle soreness. The patient was treated with CLARITIN and Cortisone Topical Cream. On an unknown date, the outcome of the injection site urticaria, generalized urticaria and muscle soreness were recovered/resolved. It was unknown if the reporter considered the injection site urticaria, generalized urticaria and muscle soreness to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on left arm. Within 2 hours of getting the vaccine, the patient experienced urticaria on his left at injection site. Within 3 to 5 hours after the urticaria was on his right upper arm. Then within 24 hours the urticaria was on both the arms, feet, back and his torso. The patient also experienced muscle soreness the day of getting the vaccine. The patient went to a clinic due to urticaria and muscle soreness. The patient was examined by a physician and nurse. The patient took over the counter CLARITIN and topical cortisone cream. The urticaria lasted for about 10 to 14 days and then he recovered. The muscle soreness lasted for about 12 to 18 hours and then he recovered. The reporter was consented to follow up.
Left arm pain at injection site.  Next day after lunch ,pt. went to sleep and  woke up with forgetfulness and time loss, falling, unsteady on his feet.
Gave child Tdap then gave Menactra after 2nd med administered child stated he felt light headed. Stated his eyes weren't focusing. Pupils dilated. called for assistance got Epi Pen. In those minutes child sat up said he was feeling better. Has been light headed before from blood drawn per child.
Headache began around 1:00 (5 hours after injection).  Woke up that night/early next morning with severe headache, fever and body aches.  Symptoms lasted all day (9-14-21) and finally subsided by the next morning (9-15-21).
Red rash on chest, back, neck, and arms (does not appear to be hives and does not itch); Two sudden, swollen nodules under my chin. Located in the center, almost directly under the center of my tongue. Very tender locally, externally; This is a spontaneous report from a contactable consumer, the patient.  A 45-years-old non-pregnant female patient  received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number:EN5318), via an unspecified route of administration in the left arm on 15Feb2021 at 09:00 (at the age of 45-years-old) as a single dose,  for COVID-19 vaccination. Facility where the most recent COVID-19 vaccine was administered was a workplace clinic.  Medical history included known  Drug Allergy to: Sulfa and Cipro antibiotics..  Concomitant medication included buspirone (BUSPIRONE), bupropion (BUPROPION), vitamin c [ascorbic acid] (VITAMIN C), vitamin d vitamin d [nos] (VITAMIN D), vitamin b complex (VITAMIN B). Historical Vaccine BNT162B2 received on 25Jan2021 at 09:00 Dose 1,  Lot Number EN5318 in Left arm.  No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 17Feb2021 at 07:00 The patient experienced red rash on chest, back, neck, and arms (does not appear to be hives,  two sudden, swollen nodules under my chin, located in the center, almost directly under the center of my tongue, very tender locally, externally. The events were considered non serious.  No treatment was  given for the event. The clinical outcome of the event Red Rash and Lymph nodes cervical swollen was not recovered.
VACCINE ADMINISTERED WAS STORED IN THE FRIDGE  MORE THAN 30 DAYS AS ORDERED BY THE MANUFACTURERER
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 11A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-061049, MOD-2021-061049 (Patient Link).   Reporter did not allowfurther contact   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow-up received on 7-JUL-2021.event outcome updated and declined consent for follow up.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
By 3pm sore throat started, hoarse, then headache started, had chills so badly that body was shaking. Had 100.2 fever, body aches (back, neck, knees hurt to the point of weakness), totally fatigued, had a bit of nausea. Put on wet compresses on head at night. The symptoms lasted for 12 hours. The symptoms were very intense by 11pm -> 12am they started to subside. By 2am they were slowing down by everything went away by 6am.
Woke up freezing and felt like someone was crushing me bones. Had troubles breathing and very nauseous. This lasted 6 days. Blood pressure went sky high and had heart palpitations. Worst reaction I have ever had to anything. Almost felt need to call squad
Information has been received from a Registered Nurse (R.N.) concerning a now 44 year old male patient with no medical history or drug allergies who on 26-NOV-2007, 03-JAN-2008 and 28-MAR-2008 was vaccinated IM with the first (lot# 656680/0010U), second (lot# 656680/0010U) and third (lot# 659265/1609U) 1 ml dose of RECOMBIVAX HB, respectively. There was no concomitant medication. Subsequently the patient found to have negative antibody titers. Hepatitis B antibody test was performed. The patient contacted nurse by phone. The patient's negative antibody titers persisted. This is one of several reports from the same source. This is an amended report. AE term now was mapped to anti-HBs antibody negative instead of negative antibody titers. Additional information has been requested.
Client reported dizziness and was flushed. Laid down on cot by EMS and felt better.
Shortness of breath; Tired; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration on an unknown date (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date, the patient experienced shortness of breath and tired. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event shortness of breath and tired was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.