chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Body chills 6 hours post injection - 12 hours post injection.; GI pain; Bloating; Diarrhea; pain at injection site; This is a spontaneous report from a non-contactable other hcp reported for herself.  A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, in Arm Left on 26Feb2021, at the age of 25-years-old, (Batch/Lot Number: EN6205) as singe dose for covid-19 immunisation. Medical history included obesity and a known allergy to Amoxicillin and Penicillin. The patient was not pregnant. The vaccine was administered at the Hospital. No covid prior vaccination, no tested for covid post vaccination. The patient's concomitant medications were not reported. The patient experienced body chills 6 hours post injection - 12 hours post injection, (non-serious) on 26Feb2021 with outcome of recovering , gastrointestinal pain (non-serious) on 26Feb2021 with outcome of not recovered, bloating (non-serious) on 26Feb2021 with outcome of recovering, diarrhea (non-serious) on 26Feb2021 with outcome of recovering, pain at injection site (non-serious) on 26Feb2021 with outcome of recovering.    No follow-up attempts are possible. No further information is expected.
09/14/2020 +Covid PCR 12/29/2020 1st Covid vaccine Moderna 025J20-2A Righ Arm 2pm 01/26/2021 2nd Covid vaccine Moderna 030L20-A Right Arm 2pm 4/21/2021 Ill 4/23/2021 Covid + PCR test 05/02/2021 Potential to RTW
This is what happen to patient after Meningococcal Vaccine. 1 He lost his voice for speech. He may be able to move his lips but his voice could not be heard. Only tears in his eyes when he is upset. He could not laugh out loud nor cry out loud only tears. 2) Became flat face no emotion at all! 3) His body became numb and weak no more activity hand became like jelly and legs became weak. He prefers to seat on the sofa with out any movement holding his stomach it could be long time of the day. (This was a child who moves the whole day run jump busy) He even did not care to play his video game that previously he was restricted to play it moderately. On general his body became just zombie he cannot say no or yes he just follows. His muscle tone became very poor!. Even when he eats his mouth area does not sense any thing dropping food all over his mouth area we had to see feeding therapist after the age of 11. 4.He could not learn at all. Does not like even to look at the book. 5.He could not control his bowel movement he had so many accidents on his pant and on the bed at. 5) His stomach became bloated all the time and constipation started. He became prompt dependent for every thing to go to the bathroom to eat to do any thing! (He was an independent boy) 6) He was just eating did not know where when his stomach was full. 7) He was diagnosed with intermittent Asthma. Any thing could attack his bacteria virus and so on. His Immune system became so weak so many absent days from school. He became allergic for different things. This is my observation and my challenge as a mother!With different treatments now he is getting a little better but not yet.He could walk faster now than before.getting better day by day.  1/19/09 Reviewed PCP medical records of 5/10/2006 which reveal patient preparing to travel to Ethiopia.  Was in usual state of good health on day of vaccination with PMH of developmental delay, speech delay, ASD.
10 days after receiving my booster, I developed bilateral red, tender nodules on my shins and calves as well as swelling in my ankles, calves, and knees. No other symptoms were present. The reaction appeared to be erythema nodosum. The number of nodules increased during the first 2 days and remained consistent for 2 weeks and then started to decrease during week 3. The swelling lasted for four weeks and will come back after standing for long periods of time. I took ibuprofen occasionally, wore compression stockings, and elevated my legs when possible.
101 fever, stiff neck, cold symptoms x 48 hrs 8 days after FluMist.
June 18  Hives on  back of both thighs no treatment June 19 at 11 AM Hives appeared on both back and front things and both  upper arms and  top of left hand; - recieved acupuncture treatment. Hives went away.  at 3 PM (post treatment)  June 19 7 PM Hives returned on front of both thighs and chest.  Took 1 Benadryl tablet.  Took additional  Benadryl tablet at 2 AM on June 20.  June 20 at 700 AM Hives on front left thigh only.  No  treatment yet (filling out form at 730 AM)
Information has been received on 08-JUL-2016 from a registered nurse. The nurse reported that an unspecified number of patients were vaccinated with PROQUAD lot # L042817 expiration date 26-APR-2017 or VARIVAX lot # L034367 expiration date 08-SEP-2017 that were improperly stored. The nurse reported the first temperature excursion occurred on 09-JUN-2016. Doses of the improperly stored vaccines were administered between 09-JUN-2016 and 08-JUL-2016. On 09-JUN-2016 the storage temperature was -10.7 degrees Celsius for hours. On 30-JUN-2016 the storage temperature was -12.5 degrees Celsius for 16 hours and 59 minutes. The storage temperature was -6.0 degrees Celsius for 24 hours at the time of the report. No adverse effects were noted. Additional information has been requested.
Shingles / Suspected vaccination failure; small painful shingles lesion on her back; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had frequent shingles outbreaks).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular) and the 1st dose of Shingrix. On an unknown date, 8 months after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Shingles / Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: small painful shingles lesion on her back).  The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 11-SEP-2023  The patient received her first Shingrix dose about 11 months ago from reporting while she had an active case of shingles (one blister that was slow to heal). She received her second Shingrix dose about 8 months ago from reporting.  She just (date unclear but 8 months after her second dose) developed her first case of shingles post-vaccination. She had one small painful shingles lesion on her back. She was not recovered and had not seen her doctor yet. Nothing else was reported. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The reported consented to follow up with healthcare professional.
The expired Jynneos vaccine was administered to the patient, intradermally; The expired Jynneos vaccine was administered to the patient, intradermally; Case reference number US-BN-2023-000050 is a spontaneous case report initially received from other health care professional via Communications (reference number: USBAV23-0057) on 11-Jan-2023 and concerns an adult patient of unknown gender.  The patient's medical history and concomitant medication details were not provided.  On 03-Jan-2023, the patient was vaccinated with the first dose of expired Jynneos vaccine (batch number: FDP00014; expiration date: 19-Dec-2022), at an unknown dose or site of administration, intradermally, for monkeypox (explicitly coded as 'expired vaccine used' and 'intradermal injection').    At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos.  Additional information received from Bavarian Nordic on 11-Jan-2023 included the local BN case ID.  This case is linked to cases US-BN-2023-000051, US-BN-2023-000052, US-BN-2023-000053, US-BN-2023-000054 and US-BN-2023-000055 (same reporter).; Reporter's Comments: An adult patient of unknown gender was vaccinated with the first dose of expired Jynneos vaccine, at an unknown dose or site of administration, intradermally, for monkeypox, which is considered as expired product administered. No associated adverse events were reported. Intradermal injection and expired product administered are listed per company convention. The patient's medical history and concomitant medication details were not provided. Intradermal injection and expired product administered are not related to Jynneos vaccine, but to a human factor. The case is non-serious.; Sender's Comments: An adult patient of unknown gender  was vaccinated with the first dose of expired Jynneos vaccine, at an unknown dose or site of administration, intradermally, for monkeypox, which is considered as expired product administered. No associated adverse events were reported. Intradermal injection and expired product administered are listed per company convention. The patient's medical history and concomitant medication details were not provided. Intradermal injection and expired product administered are not related to Jynneos vaccine, but to a human factor. The case is non-serious.
Extreme shortness of breath caused visit to Emergency. Bloodwork, lung xray, chest CT scan all okay. Received intraveneous steroid and 3 albuterol nebulizer treatments.
Immediate pain that persisted and worsened for 6 days. Pain began at injection site and moved down to elbow and wrist over 3-4 days and then resolved. Diffuse swelling of upper arm noted 2 days after injection and still persists one week later although improved. Erythematous papule of injection site measuring 2mm. Erythematous areas of 7.6cm (width) by 11.7cm (length) distal to injections site measured 3 days after injection with warmth. Resolved on own 2 days later. Both pain and redness resolved 6 days after injection but on Day 8 still with mild upper arm swelling. No treatment given just monitored.
Hot, hard painful @ site then radiated up shoulder to neck. Burning and redness to area persists. Feels more nerve like pain.
(R) arm developed edema warmth hives & itching from elbow to shoulder began few hours after the vaccine. Better with CLARITIN.
About 3 or 4 min after she got the shoot she starting feeling hot like she was fainting and dizziness; dizziness; About 3 or 4 min after she got the shoot she starting feeling hot like she was fainting and dizziness; her head was cloudy; soreness in her arm; her head was cloudy soreness in her arm and nausea; A spontaneous report was received from consumer concerning a 63-years old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced syncope, about 3 or 4 min after she got the shot she starting feeling hot like she was fainting and dizziness, her head was cloudy, soreness in her arm and nausea and soreness in her arm.  The patient's past medical history included Cancer since an unknown date. Concomitant products included metoclopramide, olaparib, metoprolol and laxatives.   On 17-Mar-2021, the patient received first of the two planned doses of mRNA-1273 (lot number: 048a21a) intramuscularly for the prophylaxis of COVID-19 infection.  Patient reported that about 3 or 4 min after she got the shot she started feeling hot like she was fainting and dizziness which lasted for a long time (1hs or 2 hours). She felt her head was cloudy, soreness in her arm and nausea and then she slept for 3 hours. At the time of report, patient was experiencing soreness in her arm.  Treatment medication included none.  No lab tests were mentioned.  The event syncope was considered as serious with criteria of important medical event.  Action taken with mRNA-1273 in response to the event was unknown.   The outcome of the event soreness in her arm was considered not resolved and all other events were resolved on 18 Mar 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
PATIENT REPORTS "FEELING FUNNY" ALL OVER. THEN SHE STARTED HAVING MUSCLE WEAKNESS AND INABILITY TO COORDINATE WALKING FROM THE FRONT DOORS OF THE STORE TO HER VEHICLE. ONCE PATIENT ARRIVED HOME, THESE SYMPTOMS WORSENED TO THE POINT OF THE PATIENT NOT BEING ABLE TO MOVE AT ALL. AT HOME, SHE WAS FEELING VERY SICK SO 911 WAS CALLED AND THE PATIENT WAS TAKEN TO THE HOSPITAL BECAUSE SHE COULDN'T MOVE.
At 8 pm the next day I felt dizziness when walking or moving head, with nausea when feeling dizzy.   The next day (October 13) I had same dizziness with tinnitus (fainting tinkling sound), partial hearing loss, and non-painful pressure in left ear.  Head felt stuffy.  No nose or eye abnormalities.  Dizziness lessened by noon on October 13, but still feel unbalanced walking and feel dizzy when moving head.  Ear problem remains but tinnitus diminished.
At first I got chilled to the bone. I had on layers of clothing and blankets, sitting in front of a fire - the indoor air temp was 71 degrees F - I was shivering uncontrollably. This lasted several hours. During that time I got a migraine (I have a history of these, so I don't know if it was related to the vaccination) - I took rizatriptan (10 mg) in response. Then there was severe nausea, achy body and fatigue. I took ZOFRAN, to prevent vomiting. The severe nausea lasted throughout the first day - it became a dull nausea, not so urgent, the second day. The achy body and fatigue lasted for 2 days. During the second day I had a tight sensation on both sides of my abdomen, up near the ribs, as if there was a tight band around me and it was pressing hard in those areas. This sensation moved down my abdomen as the day progressed, until it reached my lower abdomen. On the third day I was fine. On the fourth day I had severe nausea again. I took ZOFRAN- that cleared it up and the rest of the day I was fine. No symptoms since.
Pt received immunization, then immediately skin color went pale, proceeded to lean back and breathing became irregular - pulse ox dropped to 82 percent. Patient became diaphoretic, within 2 minutes pts oxygen went to 99%, pulse 39. Ambulance called. Pt unsteady, and still sweating. Pulse 30's up until ambulance arrived.
Moderna COVID-19 Vaccine EUA fatigue, aches, weakness, dizziness, fainting, headache mostly the morning after receiving the shot symptoms gradually subsided during the day
Initial case was retrieved from the scientific literature on 15 April 2013. Verbatim from the report: "A 35-year-old healthy man developed progressive distal symmetric numbness and paraesthesias 2 weeks after diphtheria-tetanus-pertussis vaccination. Paraesthesias initially affected only the distal portions of his hands and feet. Over the following month, sensory loss developed in the same areas. Sensory loss and paraesthesias progressed over the next month to affect the legs below the knees and arms below the elbows. Two months into his disease course, he could walk without assistance but with a slow broad-based gait. Three months into his disease course, he could not ambulate independently. Three months after symptom onset, examination demonstrated severely diminished vibration, distal loss of pin sensation, areflexia, and normal strength. Laboratory studies revealed normal vitamin B12, vitamin B6, HIV, RPR, and serum immunofixation (no monoclonal protein). Antibodies against myelin-associated glycoprotein (MAG), GQ1b, GD1a, GD1b, antinuclear antibody, anti-Ro, anti-La, and anti-Hu were absent. Cerebrospinal fluid (CSF) demonstrated elevated protein (74 mg/dL) without white blood cells. Nerve conduction studies (NCSs) were notable for prolonged distal latencies in median, ulnar, peroneal, and tibial motor nerves (30%-50% above upper limit of normal) and median, ulnar, and sural sensory nerves. Mild conduction velocity slowing was observed in several nerves. The F waves were absent (peroneal) or mildly prolonged. No conduction block or temporal disperson was present. Limb temperature was more than 32 degrees C. Three months after symptom onset, he began 2 g/kg of intravenous immunoglobulin (IVIG; divided) followed by 1 g/kg of intravenous immunoglobulin every 4 weeks. Three months after treatment, initiation examination showed vibration and pin loss only in his feet and fingertips. Reflexes were now present but hypoactive. He could ambulate independently but was unsteady and not able to perform tandem gait. Six months after treatment initiation, only a mild degree of vibration loss remained in his toes. Pin testing and reflexes normalized. Gait was stable, and tandem gait was performed without difficulty. Strength remained normal during the disease course." The reporter for this case is the same as for case 2013-05406. Documents held by sender: none.
Tingly arm, dizzy, swollen left foot, mental fogginess, feeling like passing out.
Within seconds of receiving vaccine pt leaned forward, fainting, and fell of table appearing to hit face. Regained consciousness within seconds. Began to hyperventilate. Transferred to ER via ambulance.
19JUL 4PM t102.7- 20JUL mild fever; 21JUL fever-back pain when lays down-appears to have stiff neck-loss of appetite-red throat (culture taken) seen by MD;
Client received J&J vaccine at 1:29pm. In post-vaccination observation area at 1:31pm, client's eyes rolled back in head and body went limp as he leaned back in chair (prevented from falling out of chair by employee). Lead observation nurse rushed over and attempted to give epinephrine pen into right thigh at 1:32pm. Nurse accidentally forgot to remove safety cap off the Epi-pen, so dose was not administered. Client was then arousable and started to talk, apologizing for fainting. No respiratory distress, pain, hives, rash, swelling, or any other signs of adverse reaction. At 1:37pm, vital signs were: pulse 65, blood pressure 96/67, and O2sats 97%. Client stated he had not ate or drank much at all today and complained of fatigue (temperature outside over 90 degrees with Unhealthy air quality due to wildfire smoke). Client drank 32oz water while resting on cot. By 1:59pm, client sitting up on cot and stating he feels much better. At 2:10pm, vital signs were: pulse 58, blood pressure 118/72, O2sats 97%. All questions answered and client verbalized understanding of when to seek further medical care. At 2:14pm, client stated he felt back to his baseline, was able to stand up independently without dizziness, and left without assistance.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 59-year-old female patient who received SHINGRIX for prophylaxis. On 14th May 2018, the patient received the 1st dose of SHINGRIX. On 15th May 2018, 1 days after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The reporter reported that she had a sore arm after getting a dose of SHINGRIX. By the 4th day it had mostly resolved and only hurt if she laid on it. The patient had denied permission to contact their physician.
My mom woke up at 5:30 this morning in pain. Her arm is swollen at the injection site, and very tender. She also received a tetanus shot right before her COVID-19 booster.
Swollen area noted to (R) frontal area-denies injury-denies pain with palpation.
In for immunization.  Later in evening noted to have large red spot on L shoulder/upper arm.  Initially complained of itching at site.
I received my second Moderna dose around 11:30 AM on April 8th. Around 8 pm that evening, a fever started along with intense shaking of my entire body, and severe joint pain in all joints. Also, my vision was off. It seemed like it was foggy and moving in slow motion.  I started taking Tylenol for symptoms.  In the middle of the night, my fever started to go down, and the intense shaking or shivers stopped and the visual changes resolved.  I started feeling much better but had to take Tylenol every 5 hours to keep the fever and shaking under control.  I called my APN at her PCPs office who recommended I go to immediate care for evaluation.  My daughter drove me. I still had a slight fever and dull headache.  The joint pain continued for about 3 days, along with a mild fever. Extreme tiredness continued for approximately seven days.
Case number PHEH2013US009429 is an initial spontaneous report received from a consumer who is a nurse on 06 Feb 2013. This report refers to a female patient whose age was not reported. Her medical history and concomitant medications were not reported. It was reported that on an unknown date when she picked up the MENVEO (batch number; M12004, expiry date: 30 Sep 2014), the vaccine leaked out onto her hand from a crack in the bottom edge of the vial. The carton was previously unopened and all other vials within the carton were found intact and undamaged. Both the inner and outer cartons were not damaged and customer did not observe liquid damage to the carton. No dose was administered to patient. No adverse event was reported. The quality assurance department registered a complaint with reference number 209045. No further information was provided.
rash at injection site, right arm. red, itchy, burning rash; and joint pain.  At the mpment taking Benadryl. Seeing doctor this afternoon.
he is experiencing pain in the arm; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history and concomitant medications was not reported. The patient got his 1st dose on 31Mar2021 and now he is experiencing pain in the arm on 01Apr2021. Patient also asked if he could walk around to the park to do exercise under the sun. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient got shaky, pale and had diaphoresis soon after the shoots. Got better after 45 seconds.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Additional Details: Patient complained of \" numbness \" around his lips, 5 minutes after dose given ( 1905 hours ) T 97.7 temporal, p-80 reg, R 20\r\nsaturation 97% room air. BP 110/70. Benadry 25 mg PO given per PharmD. Patient sx subsided, went home, T 98, P 76\r\nreg, R 20, saturation 99%. Instructed to report to PCP MD, call 911 if sx returned or condition worsened
COVID-19 TEST POSITIVE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced covid-19 test positive. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious.