chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial serious spontaneous case was received on 16-Oct-2017, from a non-other health professional (consumer), concerning a 60-year-old, adult, female patient. On 25-Sep-2017, the patient was administered with the influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On 26-Sep-2017, the patient experienced flu symptoms-bronchitis, sinus infection and vomiting. As of 09-Oct-2017 (reported as 09-Sep-2017), it was reported that, the patient was recovering from the events.
Patient states she developed soreness , itching and a rash at the top of her deltoid after receiving initial vaccine. then after getting 2nd vaccine the patient states she developed blisters on her right side and more blisters on her right deltoid.She broke out with blisters after the second vaccine.
This spontaneous report as received from a nurse refers to a 13 year old female patient with no medical history and no drug reactions/allergies. On 05-MAR-2014 the patient was vaccinated subcutaneously with a dose of 0.5ml VARIVAX (Merck) (lot #J009165, expiration date 24-JUL-2015, dose number unknown). There was no concomitant medication. On 06-MAR-2014 the patient experienced redness and swelling at the injection site (which measured 6 inches by 8 inches) and was also hot to the touch. The patient sought for medical attention by contacting physician. Lab diagnostics studies performed were reported as none. Lot check requested by the nurse. The outcome of the adverse events was reported as recovered on 11-MAR-2014. This is one of the several patients reported by the same reporter. Additional information has been requested.
less than 24hr p/vax mom reports fever of 103;medicated w/motrin & APAP PRN;PMD notified;fever cont x 2 days;today 5MAY98 temp 99.8 child happy & playful throughout fever episode;
Patient presented to our office 11/1/21 with left neck lymphadenopathy for 2-3 weeks.  She had her second Moderna 9/15/2021.  She denied other symptoms such as cough, runny nose etc.  Ultrasound was done 11/9/2021 and revealed posterior left cervical lymphadenopathy up to 2.1cm in size.  Patient seen in follow up 12/2/2021 with persistent left neck swelling without other symptoms other than the area was now tender to touch.  Ct of the neck done 12/15/2021 revealed left cervical lymph node 1.5cm and left supraclavicular lymph node 1.1cm.  Labs with white count low at 2.76,sed rate 11, crp 4, nl platelets.  Monospot negative 12/16/21.  LDH 159, Bartonella IgG, IgM negative 12/17/21 with white count 2.58.  Chest Xray 12/17/21 normal.   White count 2.74 12/30/21  and positive ANA with speckled pattern 1:160 observed.  White count normal at 4.1 on 1/28/22 with sed rate 10 and crp 7.  Continues to deny joint pain, rashes, mouth sores, or other symptoms other than persistent left neck lymph node swelling that seems a little smaller.  Follow up 2/4/22 with palpable 2 cm left cervical lymph node without other lymphadenopathy.
Local erythema of forearm within 48 hours of vaccine administered inadvertently as it it were PPD Local care
This spontaneous report as received from a physician refers to a 65 year old female patient. In approximately December 2012 (18 months ago), the patient was vaccinated with ZOSTAVAX (lot#, expiration date, strength, dose, and route not reported) for prevention of "shingles". The physician stated that a few weeks after receiving ZOSTAVAX vaccination the patient developed "Shingles". The patient had had (7) different outbreaks of "Shingles" since the initial ZOSTAVAX Vaccine, the patient sought medical attention through office visit. The adverse event was treated with acyclovir for 12 weeks. The outcome of the adverse event was reported as not recovered. Additional information has been requested.
7-10-15 office visit. Client reports that ZOSTAVAX (given on 7-7-15) has caused redness and discomfort (L) upper arm. (L) upper arm appears red and warm to touch from injection area to just below elbow. Client states (L) arm seems better today. Medical referral made.
24 to 48 hours post vaccination, developed redness and swelling 3-4cm surrounding injection site, with several small vesicles on skin on left upper arm.
Fatigue, congestion, coughing and shortness of breath.  Tested negative for Covid and flu at healthcare facility. On May 12, tested positive for Covid using at-home test after attending holiday family gathering.
Bad body aches,  Sharp headache, brain fog. Missed the next two days of work.
My son made a gagging/choking sound, eyes fixed and staring ahead. Hands clenched and body with jerking movement lasting approximately 30 seconds associated with vomiting during the occurrence.
Cough lasting more than 2 weeks, then Running Nose, Congestion & Sneezing
This spontaneous report as received from a certified medical assistant, refers to multiple unspecified patients of unknown age and gender. No medical history and concurrent conditions were reported for the patients. On an unspecified date in 2015, starting from and after 03-AUG-2015, the unspecified patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # K021581, expiration date 24-OCT-2016 and lot # J012520, expiration date 30-JAN-2016 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
left knee swollen: x-ray done on 3/15/21, showing nothing wrong, doppler test done on 3/19/21- no blood clots, MRI done on 4/14/21, waiting on results: shortness of breath started on 3/12/21 and lasted about 3 weeks.
Patient reported feeling very warm, like she was experiencing hot flashes. Soon after, developed rashes on arm and over other areas, such as groin, legs, neck and chest. Patient also reported feeling very anxious, experiencing "air hunger", and feeling like it was difficult to breathe. Patient reported taking Benadryl to help with reaction. Called today at 6:15pm to report this to us, stating that she felt better. Instructed patient to reach out to her doctor and seek medical treatment for rash since it was still bothering her.
pain at first, redness. Redness went away after a few days. Redness returned and expanded on arm
17 year old administered vaccine; A spontaneous report was received from a pharmacist concerning a 17-year-old consumer who received Moderna's COVID-19 vaccine and was at an inappropriate age at vaccine administration.                           The patient's medical history was not provided. No relevant concomitant medications were reported.  On 29 or 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.     On 29 or 30 Dec 2020, a 17-year-old patient was given the vaccine and is outside the lower age limit for Moderna's mRNA-1273 vaccine. No adverse events were reported.  No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The event, inappropriate age at vaccine administration, was considered resolved.; Reporter's Comments: This report refers to a case of 17- year-old patient who was administered vaccine outside the lower age limit for Moderna's mRNA-1273 vaccine, lot # unknown, Exp. unknown. There were no reported AEs associated with this case of vaccine and is outside the lower age limit for Moderna's mRNA-1273 vaccine.
approx 8 days p/vax pt  document to have Alopecia Areata; Annual follow-up provided no additional data.
Small rash at Injection site; Rash is burning and stinging; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (Small rash at Injection site) and VACCINATION SITE PAIN (Rash is burning and stinging) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 immunisation.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced INJECTION SITE RASH (Small rash at Injection site) and VACCINATION SITE PAIN (Rash is burning and stinging). At the time of the report, INJECTION SITE RASH (Small rash at Injection site) and VACCINATION SITE PAIN (Rash is burning and stinging) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No concomitant medications or treatment details reported.
body ache; Diarrhea for over 4 days; headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body ache), DIARRHOEA (Diarrhea for over 4 days), HEADACHE (headache) and FATIGUE (Fatigue) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PAIN (body ache), DIARRHOEA (Diarrhea for over 4 days), HEADACHE (headache) and FATIGUE (Fatigue). At the time of the report, PAIN (body ache), DIARRHOEA (Diarrhea for over 4 days), HEADACHE (headache) and FATIGUE (Fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient is on an known medication for blood pressure.  No treatment information was provided.
Initially after receiving his 2 month immunizations, he cried immediately then became red, eyes stared straight ahead, stopped crying, normal muscle tone then resumed crying and color normalized within 15 seconds.  Fine afterwards. At 3 pm same day, mother reported infant in her lap moving about, normal color and tone.  Suddenly became red in the face, not crying but eyes staring straight ahead and loss of tone in arms and legs.  Arms flopped to side.  Was supine in mother's lap and so unable to tell what legs were doing.  No twitching or unusual muscle movements. No crying afterwards.  Total event lasted less than 30 seconds.  Then resumed normal eye movements and extremity movements.  Was afebrile and was breastfeeding well throughout the day. At 9 pm again while suppine in mother's lap, noted again to be calm and not fussy.  Face became red, eyes staring straight ahead without focusing and arms flopped to side of body.  Slight regurgitation of breastmilk out of side of mouth.  No other unusual movements.  No stooling noted.  Again lasted around 30 seconds with then immediate resumption of normal eye movements and extremity tone and movement.  Was breathing throughout. Slept well last night and appears well this morning without further episodes experienced at this time.
Internal bleeding on the dorsal aspect of right foot, no trauma, no hit, had been really resting since I was experiencing as well shortness of breath and fatigue.  Spasmodic pain all over the vascular route of right leg, up to the internal fossa of pelvic area (above inguinal ligament). Vagal responses (feeling like fainting and swelling) when spasm would stop.  Spasms were there about every hour, for about 5 minutes.  Had trouble working (physiotherapist).  This lasted a month.  Local pain on the right dorsal aspect of the foot is still there and tendency to swell more than left foot (not at all).
Bulged lower back disk which results in numb and tickling (pin and needles) of right leg and foot. Constant discomfort and pain in testicles and low libido. Difficulty with erection.
Extreme pain; Difficulty walking pain; Right after the injection, that evening I noticed my left buctock was painful,more painful than usual- note I have bursitis in that area - then on Sunday 14MAR2021 I had extreme pain, as in difficulty; Bursitis; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the arm right on 05Mar2021 at 13:15 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included bursitis, low back ache and painful feet. The patient was allergic to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included DEPAKOTE, GEODON, ALLEGRA, and LISINOPRIL all from unknown date for unknown indication and unknown if ongoing. On 05Mar2021, the patient experienced right after the injection, that evening, noticed that left buttock was painful, more painful than usual- note, that had bursitis in that area, and on sunday 14Mar2021 at 14:00, the patient experienced extreme pain and difficulty walking pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the extreme pain and difficulty walking pain which included treatment ADVIL which eased the pain and also using ice pack. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events right after the injection, that evening, noticed my left buttock was painful, more painful than usual- note, that had bursitis in that area, extreme pain and difficulty in walking pain was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Arm Pain; Headache; itchiness; swollen; red spot; warm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Pain), VACCINATION SITE WARMTH (warm), HEADACHE (Headache), VACCINATION SITE PRURITUS (itchiness) and VACCINATION SITE SWELLING (swollen) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE WARMTH (warm), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE ERYTHEMA (red spot). On 03-May-2021, the patient experienced HEADACHE (Headache) and VACCINATION SITE PRURITUS (itchiness). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm Pain). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Arm Pain), VACCINATION SITE WARMTH (warm), HEADACHE (Headache), VACCINATION SITE PRURITUS (itchiness), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE ERYTHEMA (red spot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.    This case was linked to MOD-2021-103539 (Patient Link).
Pt recv vax on 5/18/96; 30 min post vax pt exp hives over body
High fever, seizure once, went to ER. Behavior changes for 1-2 weeks.
began c/o lt thigh pain 9PM, cont to c/o pain 19AUG98 & did not want to use leg, fever to 101 19AUG98 PM; afeb, moving well, no pain on 20AUG98;
Flu-like symptoms; fever; pain in joints; infection site pain warm; General tiredness and soreness; loss of appetite; General tiredness and soreness; This is a spontaneous case received from a consumer (Patient). A 64-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8732), via an unspecified route of administration in right arm on 29Mar2021 at 09:45 (at the age of 64-year-old) as dose 1, single for COVID-19 immunisation at other facility. Medical history included COVID 19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Mar2021 01:00, the patient experienced flu-like symptoms, fever, pain in joints, infection site pain warm, general tiredness and soreness, loss of appetite, general tiredness, and soreness. The adverse events were resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The outcome of the events was reported as resolving.  No follow-up attempts are needed. No further information is expected.
Pt had immun for DT/OPV nurse noticed about 5 min later that pt was sliding to floor into a sitting position & was pale & tremulous; MD treated pt immediately; BP 50/30, vomited small amount of clear mucous;
After 1st injection a rash developed on my chest the next day and lasted a week.  After the second injection a hyper sensitive reaction occurred after about 6 weeks later that was so bad, I had to see a dermatologist, who took a biopsy. Bumps on my face , front of my body , some on my arms and legs. Had to apply creams. It has faded on my body but is still on my face and it has been a month since I broke out.
I have had Complex Regional Pain Syndrome (CRPS) for 20 years (in remission for 18 years) until a  broken tibia and fibula  in my left ankle/leg in the late 1990's. I have a Medtroinic Pain Pump 24/7 to  deal with the pain.  Following my second COVID-19 vaccine, my body interpreted the shot as an injury which it reacted to by triggering my CRPS to kick back in. In the right arm where the vaccine was given, I had tremndous pain that traveled to my right shoulder and this pain has not gone away since that vaccine on 02/11/2021. I sought medical advise about whether or Not to take the BOOSTER given my reaction to the second vaccine. It was determined that the risks of getting COVID were greater than taking the BOOSTER,
10:30 am--15 after receiving vaccine, patient described feeling dizzy and having a hot flash.  Patient was taken to a clinic room, provided water and observed by nursing staff, vital signs BP 100/67, P. 68, R. 17, lung sounds clear bilaterally, patient alert. At 10:50 patient stated she "felt like something is in my throat" and was trying to clear her throat. At 10:51 Epinephrine 1:1000 0.3mg injected  in right upper thigh per epi injector,  10:52 am O2 started  at 15L via rebreather mask and EMS called.  At 10:53 BP 130/90, P 80, R 20, lung sounds clear bilaterally, patient alert. At 10:57 am BP 132/92 patient alert. At 10:57 EMS arrived, care of patient transferred to EMT/Paramedic. Patient transferred to hospital  via ambulance.
this case was reported by a physician via a representative and described the occurrence of an adult male subject with decreased therapeutic response following vaccination with TWINRIX (GlaxoSmithKline) for prophylaxis. On an unspecified date the subject received 3rd dose of TWINRIX (unknown) to complete the vaccination series. At an unspecified time after vaccination with TWINRIX (thought by the sales representative to be 12 months from the completion of the series), the subject was tested and found to have a decreased therapeutic response with a hepatitis B surface antibody titer of 2 IM/ml. The physician felt that there might be something wrong with the TWINRIX vaccination (product complaint). At the time of reporting the events were unresolved. The physician considered the events were probably related to vaccination with TWINRIX. The reporter gave details on two separate subjects (A0730576 ans A0730976), but indicated that there were more that received this particular TWINRIX, completing the series and not achieving seroprotection. For these additional subjects, refer to case A0731173A.
(Lt) arm paresthesia. Oxygen desaturation 91% L (99% R). Elevated blood pressure.
Initial and follow-up information has been received from a nurse practitioner concerning an 18 year old female, who, on 30-JUL-2007 at 11:35, was vaccinated intramuscularly in the right arm with a first dose of Gardasil (Lot# 657868/0523U) (previously reported as lot # 0523U,  which was a valid lot # for Varivax (Oka/Merck). On 15-AUG-2007 at 12:04, the patient got vagal. Subsequently, the patient fainted after administration and "passed out" for 30 seconds.  It was unknown if the office used a single dose vial or a pre-filled syringe. The patient's blood pressure was 102/70. The patient stayed at the office for 25 minutes and was given fluids. The patient's blood pressure was then 110/60. The patient stated that "she does this all the time." The patient did not seek medical attention. It was noted that the patient was not pregnant at the time.  The patient recovered and was fine before leaving the office.  No product quality complaint was involved.  Additional information has been requested. Additional information is not expected.
+ 1 hour: flu like, headache, sore muscles, sweating, tiredness. +18 hr: sxs starting to subside
Information has been received from a physician's office concerning a male pt who was vaccinated with pneumococcal vaccine 23 polyvalent. Subsequently, the pt developed a fever, chills, redness at the injection site, and radiating pain up and down the arm from the injection site. Two of the pt's family members had similar experiences following exposure to pneumococcal vaccine 23 polyvalent. Additional information has been requested.
Initial case was received on 18 July 2010 from a healthcare professional. A 50 year old female received a right deltoid injection of RABIES VACCINE (lot number not reported) and an injection of IMMUNOGLOBULIN HUMAN ANTIRABIES (lot number 26NCXH1-not valid) on 18 July 2010. Several minutes later, during infiltration of IMMUNOGLOBULIN HUMAN ANTIRABIES, after receiving 0.5 cc to 0.75 cc at wound site, the patient became diaphoretic, tachypneic and had a ten second loss of consciousness. The entire episode lasted 5-10 minutes. The patient's pre-existing medical conditions and concomitant medications were not reported. The outcome of the adverse events was unknown. Documents held by sender:None.
Within 2 hours of receiving  the Pfeizer booster, I developed brain fog, extreme fatigue, muscle and joint pain, and "painful skin" over my trunk and arms, as if I had a sunburn all over.  This lasted constantly for at least 3 days, then i felt mostly well in the mornings and would get exhausted along with muscle pain and very painful burning skin sensation beginning each afternoon.  I am still struggling with these symptoms and it has been a full month now.  I was placed on Gabapentin, titrating up to 300 mg TID, which helps a bit but not entirely.  I still have breakthrough pain daily.
Patient had seizure in the evening after flu vaccine.  Had just taken Benadryl/Maalox/Viscous Udocaine and Tylenol - unknown if seizure due to meds vs. vaccine.
Information has been received from a physician concerning an 11 year old male who on an unspecified date was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck) (lot# 658288/1174U). It was reported that on an unspecified date after receiving the vaccine, the patient developed cellulitis in the arm. The patient sought treatment in an emergency department. It was not specified if the patient was hospitalized. It was reported that on an unspecified date the patient had recovered. A product quality complaint was not reported. This is one of three reports from the same source. Additional information has been requested.
Hypertension stage 3 for one week (used a good pressure cuff to monitor). Dizzy, fuzzy/foggy thinking. Forgetful. Headache. I couldn't think at all. When walking it felt like I was floating above my body. Anxiousness. Tired. Out of breathe. Irregular heartbeat. Lasted about a week. Then one morning it was gone. Almost like a fever breaking but instead it was my blood pressure.