chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHHY2013US150396 is an initial literature report received from on 17 Dec 2013. The author discussed a rare case of relapse of chronic inflammatory demyelinating polyneuropathy (CIDP) after influenza vaccine. This report refers to a 78-years-old male patient. His medical history included illness with respiratory issues requiring tracheostomy after an upper respiratory infection when he was 10 years old. It was reported that he probably had an episode of Guillain-Barre syndrome (GBS) during his childhood. His concomitant medications were not reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. Few days after vaccination, the patient presented with five day history of generalized weakness. He also reported difficulty in getting up from a chair and difficulty while lifting his arm. Physical examination showed significant proximal as well as distal muscle weakness in bilateral upper and lower extremities. Sensations were preserved and reflexes were absent. His laboratory work up including electrolytes, thyroid stimulating hormone (TSH), creatine phosphokinase (CPK) and aldose levels were normal. Magnetic resonance imaging (MRI) head was remarkable. An electromyogram with nerve conduction study showed evidence of chronic inflammatory demyelinating polyneuropathy (CIDP). This episode was probably from activation of CIDP triggered by influenza vaccination. It was reported that the GBS episode during childhood might have developed into CIDP. He was promptly started on corticosteroids. He showed gradual improvement in weakness and was advised to avoid influenza vaccines. The outcome of the event was not reported. The author concluded the article stating that currently there was no definitive guideline regarding provision of influenza vaccine to someone with a history of relapse of CIDP with vaccination and that symptoms of weakness following vaccination should be promptly worked up for demyelinating polyneuropathies.
This is a spontaneous report from a non-contactable other healthcare professional (patient). A 29-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 03Feb2021 07:45 (at the age of 29 years old) (Lot number was not reported) as first dose, single dose for COVID-19 immunization. The patient did not have COVID-19 prior to the vaccination. The patient was not pregnant at the time of vaccination. Medical history was reported as none. The patent had no known allergies. The patient did not take any other vaccine in four weeks. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE) taken for an unspecified indication, start and stop date were not reported. On 03Feb2021 08:45 AM, the patient experienced tingling lips, flushing in face and heart palpitations. The events resulted in Emergency room/department or urgent care. No treatment was given for the events. The patient did not get a COVID test post vaccination. The outcome of the events was recovered in Feb 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
cough; throat hoarse; voice box hoarse; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Feb-2021 and was forwarded to Moderna on 25-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough), DYSPHONIA (throat hoarse) and DYSPHONIA (voice box hoarse) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COUGH (cough), DYSPHONIA (throat hoarse) and DYSPHONIA (voice box hoarse). At the time of the report, COUGH (cough), DYSPHONIA (throat hoarse) and DYSPHONIA (voice box hoarse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included On antibiotic for throat.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), throat hoarse, voice box hoarse, cough was unknown.
Pt had pain in deltoid that radiated to the shoulder towards the neck. Painful to move the arm.
Headache, body aches, chills, extremely sore and red injection site.  With this 2nd dose, there were less symptoms (with the first injection, I was also very fatigued with severe headache plus the other symptoms listed), symptoms were much less severe, and lasted only a day (lasted 3 days with 1st injection).
Headache on both sides; Fever 102 Fahrenheit; Feels very sick; Forget many things; Memory loss; No energy; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache on both sides), PYREXIA (Fever 102 Fahrenheit), MALAISE (Feels very sick), MEMORY IMPAIRMENT (Forget many things) and AMNESIA (Memory loss) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibromyalgia and Bronchitis.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced HEADACHE (Headache on both sides). an unknown date, the patient experienced PYREXIA (Fever 102 Fahrenheit), MALAISE (Feels very sick), MEMORY IMPAIRMENT (Forget many things), AMNESIA (Memory loss) and ASTHENIA (No energy). At the time of the report, HEADACHE (Headache on both sides), PYREXIA (Fever 102 Fahrenheit), MALAISE (Feels very sick), MEMORY IMPAIRMENT (Forget many things), AMNESIA (Memory loss) and ASTHENIA (No energy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Pyrexia: 102 f (High) 102 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter.  She had allergy to many things. She was used 5 different types of inhalers.   This case was linked to MOD-2021-193996 (Patient Link).
Tachycardia (heart rate 130), lightheadedness, shortness of breath for about one hour morning after vaccination. Symptoms resolved after about one hour followed by extreme fatigue.  I did not end up seeking medical care due to resolution of tachycardia and accompanying symptoms.
injection site swollen; injection site itchy; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 23Mar2021 at 12:30 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure, overweight and allergy to nickel. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) and metformin (MANUFACTURER UNKNOWN) for unknown indication. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021, 1 week after the vaccination, the patient experienced vaccination site swelling and itchy. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events of vaccination site swelling and vaccination site pruritis was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
When I was eating I noticed that my skin had a red spot, when I was done eating, I started scratching it, because it was itchy, I was good for two days and then suddenly starts again but this time was worse, was in my whole body, including in my neck, legs, forehead, chest, legs, lips, feet, it was covering my whole body! I went to store and I bought Claritin, I was fine I just stopped taking them and the allergies backed!
Patient received MMR and VZV about 10 minutes later pt came back with swollen eye and SOB. Treatment 1 EPIPEN Jr 15mg given 12:10pm Albuterol .5.
I had a mild bout of Pancreatitis; Suspected gallstone; Vomiting; This is a spontaneous report received from a contactable consumer (patient). A 37-year-old  non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration, administered in Arm Right on 26Mar2021 08:00 (Batch/Lot number was not reported) (at 37-year-old) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history was reported as none.  No known allergies.There was no COVID prior vaccination or no COVID  tested post vaccination. There was no other vaccine in four weeks.   The patient's concomitant medications were reported as no. The patient experienced a mild bout of pancreatitis, suspected gallstone, and vomiting on 02Apr2021 07:30. The events did not result in emergency room visit or physician office visit. No treatment received for this events. Event details reported as:  One week exactly after I received the vaccine, the patient had a mild bout of pancreatitis and suspected gallstone. Vomiting lasted 7 hours. At the time, the patient thought it was a short-lived stomach bug, but when the same thing happened after the second dose of the vaccine, it was more severe and the patient ended up in the hospital for a week. The patient never had gallbladder or pancreas issues prior to these two events. The outcome of the events was recovered with sequelae.  Information about lot/batch number has been requested.
Vaccine was picked up on 12/07/2021 to be stored in fridge and used by 01/07/2022. Patient received this dose a day past the vaccine usage date. Patient reported no known symptoms.
On 12/11/21 at 31w 5 days gestation my baby was stillborn. The autopsy report stated "immediate cause of death unknown". I tested negative for COVID19 on the day of our loss.  I had received the booster/third dose of the COVID19 Pfizer vaccine on 10/8/21. I had received the first dose of the COVID19 Pfizer vaccine on 1/7/21 and the second dose of the COVID10 Pfizer vaccine on 1/28/21.  I later contracted COVID19 on 1/4/22. I had mild symptoms and did not need to seek medical treatment.
Fever started eight hours after vaccine. Rash 12 hours after vaccine. 3 soft stools 24 hours after vaccine.
Fatigue, achiness, not feeling well on the evening of the shots.  On 12-1-2011, noticed her arm where the varicella was given was red swollen  and felt hot.
Information has been received from a physician concerning a healthy 23 year old female nurse with a history of mole removal who on 03-APR-2007 was vaccinated intramuscularly into the left deltoid with her first dose of GARDASIL (lot # 657617/0384U). On approximately 18-APR-2007, fifteen days post vaccination, while being used as a model for an ultrasound, it was detected that the patient had pericardial effusion. The patient sought medical attention. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 7/6/2007.  Initial and follow-up information has been received from a physician concerning a healthy 23 year old white female registered nurse with a history of mole removal who on 03-APR-2007 was vaccinated intramuscularly into the left deltoid with her first dose of GARDASIL (lot # 657617/0384U).  On approximately 18-APR-2007, fifteen days post vaccination, while being used as a model for an ultrasound, it was detected that the patient had pericardial effusion.  The patient sought medical attention.  The patient had no symptoms and the pericardial effusion resolved spontaneously.  Additional information is not expected.
Day 8 after vaccine, the injection site was swollen, firm, and itchy.  By Day 9, itching is gone, but swelling and firmness remain. No color change. In the weeks prior to the vaccination, I had been experiencing muscular pain in my back which was treated by acupuncture. After the vaccination, the muscle pain returned and continues.
HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-APR-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headache was not reported. This report was non-serious.
Started 12/30/21 with chill and a headache that  is currently on day seven. . Three days ago I  added muscle and joint pain to my growing list of adverse reactions.  It hurts everywhere in my body. I feel strange and have barely eaten anything over the past 3 days. I also have  had a low grade fever of the past three days. I have had to call in sick for work for the past three days.
Patient states he began to experience symptons 2 days after the shot.  He is experiencing chills, sweats, body pain, difficulty in coordination,
Patient had immunizations on 5-19-08 and was found in bed on back today.  7/18/2008 Autopsy report received with COD:  Sudden Unexplained Infant Death. Report states infant had some chest congestion x 2 days for which no medication used for tx. Infant had been acting normally with no other recent c/o. Infant had fed at 1 am and at 4 am parent noted infant was not breathing.
10 days post vaccine developed chest pain, tightness, nausea, lightheaded , tachycardia, bradycardia, GI, Weakness, Fatigue, Shortness of breath which continues
Had the first shot a few months ago an did not get the second shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Had the first shot a few months ago an did not get the second shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Had the first shot a few months ago an did not get the second shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Had the first shot a few months ago an did not get the second shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact
This case was reported by a other health professional and described the occurrence of wrong vaccine administered in a 12-year-old female patient who received INFANRIX (batch number AC14B169BA, expiry date 20th March 2015). On an unknown date, the patient received INFANRIX. On an unknown date, an unknown time after receiving INFANRIX, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown. Additional information received: 12 yo vaccinated with INFANRIX, HCP intended to provide BOOSTRIX. No other information was shared.
32-year-old woman who at approximately 9 weeks pregnant receive the first shot of Materna COVID-19 vaccine on August 19.  10 days later she developed numbness, tingling, weakness, balance difficulties to the point that she was not able to walk.  She was admitted to hospital, diagnosed with Guillain-Barré syndrome, received IVIG.  She is improving.  She still has neurologic deficits based upon my evaluation as of 9/23/2021.
This spontaneous report received from a patient concerned an adult female of an unspecified age (at time of event), race and ethnic origin (age at time of vaccination: 51 years). The patient's height, and weight were not reported. The patient's concurrent condition included: psoriatic arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on 20-APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. Non-company suspect drug included: Humira (adalimumab) (solution for injection in pre-filled pen, subcutaneous, batch number and expiry were not reported) dose, frequency, and therapy dates were not reported for psoriatic arthritis. No concomitant medications were reported.  On an unspecified date, the patient experienced psoriatic arthritis flare up (one/two days before Humira shot), purple bumps on bottom of feet/patches on hands, osteoporosis in hands, chronic cough, red bumps at injection site on stomach, peeling of fingers, wearing off effect, knots on fingers, redness, swelling, and painful finger tips. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The patient had not recovered from osteoporosis in hands, psoriatic arthritis flare up, chronic cough, and wearing off effect, and the outcome of purple bumps on bottom of feet/patches on hands, bumps at injection site on stomach, fingers peeling, knots on fingers, redness, finger tips painful, red bumps at injection site on stomach and swelling was not reported. This report was serious (Other Medically Important Condition). This report is associated with a product quality complaint.; Sender's Comments: V0: 20211120809- Covid-19 vaccine ad26.cov2.s- Psoriatic arthritis flare up. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY 20211120809-Covid-19 vaccine ad26.cov2.s- Wearing off effect. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
This spontaneous report as received from a pharmacist refers to a 62 year old female patient. The patient's pertinent medical history was not reported. Patient's concurrent conditions included high cholesterol and high blood pressure. Patient is allergic to sulfa drugs. On 28-OCT-2015 the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, frequency were not reported) lot # L012609 with an expiry date of 10-SEP-2016, subcutaneously. Concomitant therapies included acetaminophen, hydrocodone/APAP, zolpidem tartrate, simvastatin, furosemide and carvedilol. On 29-OCT-2015, 2 days after vaccination the patient developed bright red, hot, welt at the site of injection. The patient did not receive treatment for the events. The patient sought medical attention by visiting the pharmacists. The outcome of events injection site erythema, injection site warmth and injection site urticaria was reported as not recovered. The reporter did not provide the causality between the event and the suspect therapy. There was no product quality complaint. Additional information has been requested.
This spontaneous report was received from a medical assistant referring to a 5 month old female patient. The patient had not pertinent medical history, drug reactions/allergies, concurrent conditions or concomitant medications. On 28-MAR-2018, the patient was vaccinated with ROTATEQ lot # N013884 with expiration date 05-DEC-2018, orally, for prophylaxis (dose was not reported). On 09-APR-2018, the patient received a a coronary artery bypass. The patient was hospitalized and an unspecified treatment was given for the event. No laboratory/diagnostic test was performed. At the time of reporting, the outcome of the event was reported as recovered on a unspecified date in 2018. The causality assessment between the event and ROTATEQ was not provided. Upon internal review, coronary artery bypass was determined to be a medically significant event.
A number of pts recvd Engerix-B & exp pain @ inject site due to this pharmacy no longer uses Engerix-B but has switched to Recombivax HB;
Sudden sensorineural hearing loss 2 days after vaccination - unilateral - occurred over few hours period of time.
Received Flu and PNEUMOVAX 3/24/09 one in each deltoid. Pain since - Limited range of motion, very painful. Referred to physical therapy - Given pain meds. Last seen 4/21/09
Erythema nodosum, moderate-- tender papules of panniculitis on shins and ankles. Resolved within one week.
pt was hospitalized exactly 1 week after both 1st and 2nd doses of moderna covid-19 vaccination.  timeline: 2/13/21 PCP office visit with presumed covid, tested neg but symptomatic and exposed to positive household members 3/4/21 hospitalized with new diagnosis acute pulmonary embolism  3/13/21 ER visit with  new left anterior thigh pain and swelling 3/17 received 1st dose of COVID-19 Moderna and MC lot # 026A21A 3/24/21 hospitalized exactly one week later with LLE LUE and left neck numbness. determined multiple sclerosis exacerbation. however patient notes her symptoms were significantly worse, total numbness which she'd never experienced before and newly int he leg (though that started a few days prior). per daughter and patient's separate accounts she also had significant dizziness lethargy and syncopal episodes with loss of consciousness which she had never experienced before, not noted in hospital notes.   4/3/21 ER visit for hemoptysis and cough. positive covid exposure during admission via hospital roommate. patient tested neg x2 4/14/21 received 2nd dose covid-19 moderna vaccine lot # 044A21A 4/15/21 vomited 8 times that night. nausea and poor appetite persisted for a week 4/21/21 hospitalized for dizziness, slurred speech, syncopal episode and "multiple sclerosis flare" of left sided total body numbness and facial changes. per daughter and patient she had a complete loss of consciousness at a restaurant leading to this ER visit and was completely "unresponsive" for some time prior to arrival at hospital. daughter and patient in separate accounts report patient to be "very ill" immediately after each vax administration for 2-3 weeks, gradually improved, then suddenly much worse again after subsequent dose. aware of possible contributing factors. is concerned vaccine itself may have exacerbated symptoms, aware possibly poor po intake secondary to feeling unwell from typical side effects a contributor ; concerned for triggering exacerbations.
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hyperventilation-Severe, Systemic: Weakness-Severe