chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderna covid-19 vaccine was administered to a patient aged 17, under the approved age of 18. This was done due to misrepresentation of the birthday by the patient. No adverse event occurred besides off-label use of the vaccine.
I only had a one day menstrual cycle on March 31st when normally it's 4 days with spotting and other pms related symptoms.
Patient showed a very small rash on the 16th near his butt and testicles. We applied cream and thought it was diaper rash. The next morning we took him to the nanny. When I picked him up he had a rash on his arms, legs, and chest. Took him to the urgent care. 530pm. Doctor said he didn?t know what it was and to monitor. Called doctor and sent him photos. Doctor reached out to me at 10pm and  asked to begin administering Benadryl every 6 hours until he could see him Monday. Said to take him to hospital only if he had a fever. Otherwise stick to the Benadryl. Today Sunday he has a rash throughout his chest, arms, legs, butt, and testicles.
The muscle twitching in the left arm  started intermittently, slowly increased the frequency.  Now, I am getting it a lot and not able to sit or sleep.
While the recipient was in the observation area, she started to experience breathing difficulties.  EMS on site responded and escorted her back to their privacy area for examination. Based on the symptons the recipient was experiencing, they suspected a possible Anaphylactic reaction.   Recipient was transported to the hospital by on site EMS. The recipient has a history of allergic reactions to the flu vaccine.
Within 1 hour of injection I was extremely tired; not sleepy, but very fatigued. About 1.5 hours after that began, I had a headache & felt hot, though no fever. Within an hour I was experiencing all-over muscular body ache than extended throughout my body. Severe muscular ache & soreness @ injection site (top of right arm, near shoulder). All of these reactions (headache & heat included) continued all of the next day & the following day. By the third day I experienced less of everything  adverse & was feeling much better. My next injection is 4/16.
This case was reported by an unknown source and described the occurrence of not responding to therapy in a male subject aged between 50 and 59 years old who was vaccinated with Twinrix for prophylaxis. Co-suspect vaccines included hepatitis B vaccine (unknown manufacturer). The subject's medical history included allergies, codeine allergy and gout. Concurrent medications included Allopurinol and Zyrtec. In the early 1990's, the subject received his first hepatitis B vaccination series. Three days following his first immunization with Twinrix in the early 1990's, the subject developed a low grade fever, lower back pain, and dark urine. The subject was examined by a physician, and reported that he was advised to complete the hepatitis B vaccination series. The symptoms resolved a few days after onset, and the subject subsequently completed the first hepatitis B vaccine series. In the early 1990's, on an unspecified date following completion of the first hepatitis B vaccine series, a hepatitis B titer was negative. In the late 1990's the subject again completed a hepatitis B vaccine series. In the late 1990's, on an unspecified date following completion of the second hepatitis B vaccine series, a hepatitis B titer was again negative. in 2005 the subject completed the vaccination series for Twinrix (unknown). Approximately 2 years after completion of the Twinrix vaccination series, a hepatitis B titer was again negative. At the time of reporting the event of not responding to therapy was unresolved.
This spontaneous report was received from a nurse. The nurse reports that 3 patients of unknown age respectively were mistakenly vaccinated with (Merck) VARIVAX instead of ZOSTAVAX on 28-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. No treatment information was reported. No adverse effects were reported. The relatedness for vaccinated with VARIVAX instead of ZOSTAVAX was unknown for (Merck) VARIVAX. No further information is available.
Information has been received from a physician concerning a male who in approx. 1/02, was vaccinated with 1 dose of MMRII (lot 640562/1374L). Concomitant therapy included 1 dose of varicella (lot 641151/1181L). On 1/15/02, the pt developed a temperature. This information was called in to the physician's office. The pt sought unspecified medical attention. The physician requested a lot check on the lots because there were "more phone calls than ever before", for MMRII (lot 640562/1374L) and varicella (lot 641151/1181L). It was found that, "The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. This lot complies with the standard of the Center for Biologics Evaluation and Research and was released." F/U info on 3/7/02, from a physician, noted there were no more adverse events to report other than those that were previously reported. The physician stated that the reason she used the phrase "more calls than ever", was because she has been in practice for a number of years and always gave pt/parents standard info on the benefits/risks of a vaccine before its administered, and also instructed them to call the office if the child experienced any problems, post vax. The physician reported that in her years of practice, it had been her experience that parents very rarely call their office to report a post vax reaction. It was very unusual for their office to receive as many calls as they did in 1/02, including this pt and other pts who were vaccinated and experienced similar events (WAES021USA03018, 0202USA00429, 0202USA00430, 0202USA00431 and 0202USA00432). The physician also thought it was unusual that several of the adverse events seemed to be occurring at day 10, post vax. It was noted that there were no additional cases reported and the increase in calls was just in the month of 1/02. They did not experience any unusual volume of calls in February or thus far in 3/02. Additional info has been requested.
With first dose of Moderna vaccine, I had a Raynaud's attack in my hands. After second dose, I had a Raynaud's attack in my feet. Neither attack was severe, but my Raynaud's has always been very mild.
headache/ his head was really pounding; nausea; chills; he had no appetite; This is a spontaneous report from a contactable consumer (patient). A 41-years-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EL1284, Expiry Date: Apr2021), via an unspecified route of administration in the right arm on 31Dec2020 at 14:00 at single dose for COVID-19 immunization as front line health care worker. There were no medical history and no concomitant medications.  The patient received the Pfizer COVID 19 vaccine first dose 31Dec2020 at 14:00 in the right arm and then experienced a headache, nausea, and chills on 02Jan2021. He took two days off from work and now felt better, had no more symptoms. He noticed the symptoms on Saturday 02Jan2021, then Sunday he was able to go to work then he took off on Monday because the symptoms got worse. He had no appetite on 02Jan2021. Today he felt great. He was supposed to get the second dose 21Jan2021. He did take Ibuprofen with strength 600 mg oral once on 02Jan2021, because his head was really pounding and then he went to sleep and it was better the next day. He had no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on same date of the Pfizer suspect. There were no prior vaccinations -within 4 weeks. There was no family medical history. He had the COVID 19 test 3 months ago in 2020 and it was negative. The outcome of the events was recovered on 04Jan2021.
This spontaneous report was received from a 25 year old female patient, referring to herself, with no pertinent medical history and no drug reactions or allergies. Concomitant therapies included LOW-OGESTREL for unknown an indication. On an unknown date in November 2016, the patient was vaccinated with the first dose of GARDASIL for prevention of human papilloma virus (HPV) (dose, route, frequency, lot/batch # and expiration date were not reported) and it was used DILUENT MRK (dose, route, frequency, indication, lot/batch # and expiration date were not reported). On an unknown date in February 2016, her second vaccine was GARDASIL 9 for prevention of human papilloma virus (HPV) (dose, route, frequency, lot/batch # and expiration date were not reported) and it was used DILUENT MRK (dose, route, frequency, indication, lot/batch # and expiration date were not reported). On an unknown date in February 2017, reported as "after receiving the GARDASIL 9", the patient had pain at the injection site immediately afterward and then developed a lump a week after and "felt like a bruise". The patient did not seek medical attention, did not received treatment for the adverse events, did not have laboratory diagnostic studies performed, and did not need hospitalization. The adverse events lasted until "sometime in April of 2017", and it was reported that the patient was waiting for medical information from her health care provider before receiving further vaccinations. The causality between pain at the injection site, lump and felt like a bruise with GARDASIL, DILUENT MRK and GARDASIL 9 was not reported. Additional information is not expected because there is no consent to contact the reporter.
PT SAYS HE GOT MODERNA VACCINE on 3/3/2021, PT SAYS HE WAS EXPERIENCING HIVES, URGENT CARE DIGNOSED HIM ON 3/19TH AS having DERMATITIS, AND WAS GIVEN CLOTRIMAZOLE-BETAMETHASONE, PT SAYS HE WAS SNEEZING a lot as well
No bad side effects day of vaccination . Next day was rough: stiffness, aches, headache, weak and exhausted all day. Following day; back to normal
COVID infection following COVID vaccine series 02/10, Pfizer, dose #1 03/04, Pfizer, dose #2 10/02 Pt cc: dyspnea, cough, myalgias, fatigue, cough, exposure: unknown 10/12 pt admit to medicine cc shortness of breath : dx: ACUTE HYPOXIC RESPIRATORY FAILURE DUE TO COVID-19 PENUMONIA LOS: 10 days 10/21 u/s abdomen impression: 1. New bilateral obstruction or pneumoperitoneum. 10/12 CXR impression: 1. New bilateral airspace opacities could relate to pneumonia, including viral. 10/12 CTA PE impression: 1. Technically suboptimal study. No pulmonary embolus in the large central pulmonary arteries. Limited evaluation of the segmental and subsegmental pulmonary arteries. 2. Nonspecific groundglass densities in the lungs probably represent covid 19 pneumonia. Pleas correlate clinically and follow-up as appropriate. 3. Right Pulmonary nodules measuring up to 1.9 cm as above are again noted. Further evaluation and follow-up will be helpful as clinically appropriate. 4. Mild splenomegaly. 5. Nonobstructing left renal calculus. 10/12 TROPONIN I: <0.016 10/12 PT/INR: 16.7/1.49 10/12 FERRITIN: 1035.7 10/12 CRP: 11.387 10/12 PROCALCITONIN: ,0.05 10/12 BNP: 12.0 10/12 COVID swab, result: detected 10/12 DDIMER: 0.98 10/12 SARS-COV-2 Variant Sequencing result: pending 10/12 ABG i-pH 7.47, i-PCo2 38, i-PO2 61, i-HCO3 27.3 10/13 FIBRINOGEN: 480 10/13 DDIMER: 0.83 10/13 ESR: 44 10/14 FIBRINOGEN: 406 10/14 DDIMER: 0.59 10/14 EST: 25 10/14 ABG: I-pH 7.44, i-PCo2 41, i-PO2 66, i-HCO3 27.8 10/15 FIBRINOGEN: 296 10/15 DDIMER: 0.60 10/15 ESR: 27 10/16 FIBRINOGEN: 300 10/16 DDIMER: 0.72 10/16 ESR: 18 10/17 FIBRINOGEN: 253 10/17 DDIMER: 0.92 10/17 ESR: 18 10/18 F8BR8H9GEH: 240 10/18 DDIMER: 0.93 10/18 ESR: 19 10/19 FIBRINOGEN: 242 10/19 DDIMER: 0.90 10/19 ESR: 13 10/21 FIBRINOGEN: 220 10/21 DDIMER: 0.67 10/21 ESR: 6 08/21 FIBRINOGEN: 197 08/21 DDIMER: 0.83 08/21 ESR: 4
Client passed out after receiving vaccine.  Stated ? I felt weird and than blacked out?.  Client hit head on floor when passed out
Pfizer COVID-19 Vaccine EUA Moderna COVID-19 Vaccine EUA  Patient received first dose of COVID vaccine as Moderna on 1/28/2021 from a non-BSWH facility. The patient received a dose of Pfizer vaccine on 4/7/2021.
cold; The initial case was missing the following minimum criteria: unspecified event and number of patients. Upon receipt of follow-up information on 23Aug2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient's colleague). A male patient of unspecified age and gender received BNT162B2, (Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2, lot number unknown, via an unspecified route of administration on an unspecified date, as single dose for COVID-19 immunization. After second dose, on an unspecified date in 2021, the patient experienced cold. The outcome of the event was unknown.  The lot number for [BNT162B2] was not provided and will be requested during follow up.
2 days after administration of PNEUMOVAX, patient noticed itchy rash at site of injection. In the days following, he developed diffuse maculopapular rash which spread across entire body, sparing only face and distal extremities. He was started on a course of prednisone 50 mg daily for 5 days.
It has been 5 days since I had the 3rd dose of PFIZER, the area is swollen, red with itchiness and hot.
Sore arm. Tired. Starting about 9 PM Chills and headache. Chills lasted 2  1/2 hrs. Just cold after chills gone and T. 101.4. This morning  headache and T. 100.6. I had no problem with the first Moderna, just sore arm.
Thirty minutes after receiving the shot my ears started ringing very loudly and all of the noises around me became amplified. 24 hours post vaccine the tinnitus and sound amplification has not improved. I am not disoriented or dizzy.
Dizziness/lightheadedness that lasted approximately one minute then subsided. Symptom occurred approximately 1 minute after vaccine was administered. Similar symptoms occurred during the first vaccination as well. No treatments were administered/needed.
Spoke with patient and describes the redness as a bulls eye with 1 x 2 inch center that's red and 1-2 inch pink area around the red center.  He stated it's not really swollen but there is some tenderness but only notices that at night when he's trying to go to sleep.  Educated patient to take Chlor-trimeton or Benadryl for redness.  Patient prefers to take loratadine.  3/28/2011 - patient reported pinkness has gone away and some redness still remains in the center but it's much better.
Large reddened area at injection site. (Left vastus lateralis) increased in size from 3/26 - 3/27. Itchy, hard, warm. Prescribed CLEOCIN TID for 10 days.
Pt. received PNEUMOVAX 23 and AFLURIA vaccine in the same arm (1 inch apart) the morning at 8:30 at (pt work location) as part of a flu clinic -> came in at 3:15 with severe sore and swollen arm. Arm warm to touch and stiff and sore arm with limited ability of movement. Pt also says she has a mucus sensation in her chest. Advised her that I will inform her Dr. and for her to take ibuprofen for the inflammation and pain.
No adverse event; vaccine that was given 1 day after calculated beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine that was given 1 day after calculated beyond use date) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 31-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine that was given 1 day after calculated beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine that was given 1 day after calculated beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (vaccine that was given 1 day after calculated beyond use date).    No concomitant medication was reported. It was reported that a vial of vaccine that was given 1 day after calculated beyond use date. Beyond Use date calculated was 30-May-2023 Patient was given 1 dose. No other temperature excursions occurred during storage or transport.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-Jun-2023: Follow up received contains Non-significant information
Initial and follow-up information has been received from a nurse practitioner concerning a 1 year old male who was vaccinated with his first dose of measles virus vaccine live (Enders-Edmonston) (+) numbs virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot# 656613/0414U) in the right ventralis lateralis. The patient developed a rash. No medical attention was sought. The outcome was unknown. There was no product quality complaint. This is one of three reports from the same source. Additional information has been requested.
Muscle pain in affected arm itching, swelling, redness welt (not growing) patient saw physician assistant, who diagnosed her with a Type II skin infection and prescribed an antibiotic.
administered FLUBLOK to a 13 years old patient with no reported adverse event; Initial information received on 14-Jan-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 13 years old male patient who took administered INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV]  with no reported adverse event while receiving vaccine   The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On 13-Jan-2022, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE  via intramuscular route in unknown administration site (strength, formulation, lot QFAA2125 and expiry date was unknown) for prophylactic vaccination..  On 13-JAN-2022 the patient developed a non-serious  event "administered flublok to a 13 years old patient with no reported adverse event "(product use issue) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Action taken with QUADRIVALENT RECOMBINANT INFLUENZA VACCINE (FLUBLOK QIV) was not applicable.  It was not reported if the patient received a corrective treatment for the event (administered FLUBLOK to a 13 years old patient with no reported adverse event).  At time of reporting, the outcome was Unknown for the event administered flublok to a 13 years old patient with no reported adverse event.  Reporter causality: Related
After my first dose in the middle of the night I had an extreme arm pain from my left shoulder down to my finger tip that caused numbness of my fingers, I could not move my arm due to pain, I was not even able to roll over and sleep on it because the pain was so intense. The severe pain lasted about 2 days and my arm was sore for about a full week after.
12/20/22   I had congestion, coughing and felt like I had a bad cold. As it progressed, the cough became worse, I was tired and I began feeling achy, nothing would knock it. I took an at home COVID test on 12/23/22 around 10:00 am and it was positive. I called the doctor?s office and he prescribed Paxlovid. I began taking the Paxlovid on 12/23/22.  The symptoms gradually got better. After finishing the Paxlovid, my symptoms were gone.
This spontaneous report as received from an other health professional refers to a 12 month old patient. On 17-JUL-2014 the patient was vaccinated with M-M-R II (HSA, lot # J015503, EXP 05-DEC-2015, dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
within 3 min of receiving the vaccine, I experienced flushing, racing heart, lightheadedness, dizziness, mentally fog, winded/ shortness of breath, and felt like an adrenaline rush.  All that calmed down by 30 min. Then experienced nasal congestion for an hour.  within 3 hours of vaccine, developed a headache and later that day it worsened and chills developed.  The next day was just slight headache. The second day was sore arm and fatigue that lasted for 1 to 2 more days.
PT HAD KNOWN SYNCOPAL HX, DID NOT INFORM VACCINATOR. AFTER VACCINATION, HAD A NEAR-SYNCOPAL EVENT.  PT WAS LAID DOWN WITH FEET ELEVATED. PT RECEIVED EVALUATION FROMCLINIC STAFF AND REFUSED EMS EVAL, AND FURTHER TREATMENT/TRANSPORT.
Patient reported intermittent bilateral chest pain and left armpit pain occurring almost immediately following vaccination. Reported sharp left-sided chest pains that caused some difficulty breathing that started almost immediately (same day) after receiving vaccine. Pain continued the week following the vaccine almost every day, and was described as sharp. Had dyspnea with exertion and intermittent breast and chest pains into August following the vaccination. Was seen by a different provider twice in June following  her vaccination for these complaints
Muscle weakness, trouble walking, psychiatric changes - starting early September.  9/30/08 Reviewed hospital medical records of 9/21-9/22/08. FINAL DX: facial palsy, weakness, slurred speech Records reveal patient had asthma exacerbation requiring intubation & ICU stay shortly s/p HPV injection.  While in ICU began having thigh & back pain & weakness which progressed over 3 wks until unable to walk.  Developed slurred speech, HA & tongue deviation.  Had been seen in other hospitals & w/u WNL.   10/21/08 Reviewed hospital records of 9/12-9/17/2008, ER records of 9/5-6/08. FINAL DX: no d/c summary available Records reveal patient experienced asthma exacerbation & hospitalized 8/08 in PICU.  Developed leg pain, toes pointing in w/walking, tingling in toes, numbness in forearms that resolved.  Seen by PCP & labs revealed elevated LFTs.  Leg pain progressed & had difficulty walking, HA, back pain.  Seen in ER 9/6/08.  admitted 9/9/08 for evaluation of possible GBS.  CSF & EMG were WNL & developed n/v s/p spinal tap.  Had missed several weeks of school.  Neuro eval WNL.    10/7/08 Reviewed hospital medical records of 9/9-9/12/2008. FINAL DX: LE pain & weakness; elevated liver enzymes Records reveal patient experienced pain in back & extremities, ataxia, swelling of feet/ankles, numbness/tingling left arm, unable to walk, drug induced HA & skin rash(tegretol).  Neuro consult done.  Transferred per parental request.   1/27/2010 Was seen by several neurologist-multiple test done and no abnormalities found to explain her symptoms. More than on newurologist suggested her symptoms were related to a "conversion reaction" and suggested psychiatry evaluation.
Left arm with dull erythema, warmth and swelling 10cm x 10cm. Treat with Tylenol and Motrin, ice.
Immediate rash developed which started at limbs (extremities) and spread immediately (2-3 minutes) up trunk and upper extremities; (very fine macular rash). Child has no difficulty with respiration until was seen by pediatrician and had developed rash and wheezing.