chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fatigue; chills; headache; a rash from her face to her waist; fever; pain at injection site; This is a spontaneous report from a contactable nurse reporting for herself. A 53-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date: not reported), via an unspecified route of administration on 20Jan2021 at a single dose on the right arm for COVID-19 immunization. Medical history included gluten sensitivity; she develops a rash when she eats gluten. Concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was either EJ7685 or EJ1685, expiry date: not reported), via an unspecified route of administration on 30Dec2020 at a single dose on right deltoid for COVID-19 immunization and experienced pain at injection site; patient was 53-year-old at the time of vaccination. The patient received the second dose of the COVID vaccine on 20Jan2021. On 21Jan2021, she experienced fatigue, fever, chills, headache, which have resolved. However, on 21Jan2021 later in the evening she broke out in a rash. She reported that she is gluten sensitive. She asked if there is any gluten involved in the 2nd dose and if they do grow anything for the serum that might be gluten contained. The patient also experienced pain at injection site with second dose on 21Jan2021. She experienced fever, chills, headache and fatigue. She has a rash from her face to her waist. She has a gluten sensitivity and develops a rash when she eats gluten. She didn't see it on the information sheet. She is wondering if any aspect of the vaccine was grown containing grain. She will be seeing her doctor on Monday. She has a fever where she takes her temperature on the skin that is elevated with the rash. She does not have a fever on the areas that she does not have a rash. She noticed the rash late on 21Jan2021. She had a long sleeve on during the day. She still has chills at night. The patient reported the events as non-serious. Outcome of the event fatigue was recovered on 22Jan2021, of headache was recovered on an unspecified date, in Jan2021 of chills and pain at injection site was recovering, while outcome of other events was unknown.
Temperature of 101 degrees F, Body Aches. Patient took Tylenol and symptoms relieved in the morning.
PATIENT BECAME DIZZY AND FAINTED BRIEFLY(SECONDS). PATIENT DID NOT LIKE SHOTS. HELD HIM AT PHARMACY FOR 30 MINUTES UNDER SUPERVISION. GAVE WATER. CONFIRMED HE HAD A RIDE HOME AND FELT 100%
About an hour after receiving three vaccinations, patient was very sleepy and whined more than usual.  After a few minutes of acting restless he started a high pitch screaming fit that lasted about an hour off and on.  There was no fever before or after this occurrence.
Information has been received from a certified medical assistant (C.M.A.) referring to multiple unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unspecified dates, the patients were vaccinated with doses of improperly stored GARDASIL 9 (lot # L011846, expiration date 16-JUN-2017, dose and route were not reported). No adverse effects were reported. This is one of two reports received from same reporter. Follow up information has been received on 30-OCT-2015 that all telephone attempts to obtain follow-up information had been unsuccessful. Additional information has been requested. Narrative was updated. A new case # 1511USA001527 with correct aware date was created as it was determined that a case # 1509USA007962 was sent to distribution with an incorrect aware date.
Info has been received from a licensed practical nurse (LPN) concerning a 39 year old female with an allergy to codeine and theophylline, asthma and depression and a history of a prior vaccination with pneumococcal vaccine 23 polyvalent who on 10/15/2002 was vaccinated in the deltoid (not specified) with a 2nd dose of pneumococcal vaccine 23 polyvalent (lot #643783/0709M). Concomitant therapy included amitriptyline hydrochloride (MSD), albuterol sulfate (+) ipratropium bromide (COMBIVENT), efenlafaxine HCl (EFFEXOR) and fluticasone propionate (+) salmeterol xinafoate (ADVAIR). On 10/15/2003, a few hours after administration of the vaccine, the pt developed erythema, soreness, swelling and pain around the injection site. The LPN also reported that movement of the pt's deltoid was described to be painful and limited. The pt was prescribed naproxen, 500 mg twice a day, and metaxalone (SKELAXIN) as intervention treatment. The outcome of the pt's events was unknown. The reporter expressed a concern regarding the lot number. Conflicting info has been received from the LPN. The LPN reported that on 10/16/2002 the pt was vaccinated IM in the right arm with a dose of pneumococcal vaccine 23 polyvalent (lot #643783/0709M). On 10/16/2002 the pt was unable to fully extend right arm where the injection was given. The pt's right arm became red, warm to touch, slightly edematous with much pain and the pt "couldn't sleep all night". The outcome of the pt's experience was unknown. No additional info is expected. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Anaphylaxis-Mild, Additional Details: Patient came to the pharmacy with a caregiver, ask if she should go to ER with signs of anaphylaxis,,hives and shortness of breath. The caregiver asked if they should go to the ER,, counsled yes and to take 2 benadryls. The caregiver came back and said she will not make it to the ER,,socalled 911 and they picked her up,while waiting she asked for benadryls so i gave her 2 tablets from the emergency kit. This incident report is not involving any injection or Covid vaccine..
patient c/o left arm numbness, tingling and "felt cold" from vaccine site down through her left hand
Fever; Headache; Flu l ke aches; Tiredness; This case was reported by a consumer via other manufacturer and described the occurrence of fever in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included asthma and fibromyalgia.   On 4th January 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced fever, headache, flu-like aching and tiredness. On an unknown date, the outcome of the fever, headache, flu-like aching and tiredness were unknown.   It was unknown if the reporter considered the fever, headache, flu-like aching and tiredness to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself. The patient received 1st dose on left arm. The patient experienced fever, headache, flu like aches and tiredness. The consent to follow-up was requested.
Severe fatigue; Extreme body ache; This non-serious case was reported by a physician via sales rep and described the occurrence of fatigue in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17-JUL-2023, the patient received the 1st dose of Shingrix. On 18-JUL-2023, 1 days after receiving Shingrix, the patient experienced fatigue (Verbatim: Severe fatigue) and general body pain (Verbatim: Extreme body ache). The outcome of the fatigue and general body pain were resolving.   It was unknown if the reporter considered the fatigue and general body pain to be related to Shingrix.     It was unknown if the company considered the fatigue and general body pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-JUL-2023 The reporter reported that the patient received Shingrix vaccine and experienced adverse reaction. The patient had severe fatigue and extreme body ache 1 day after received vaccination. The reporter stated that on 20th July 2023 the patient was mentioned that she felt much better . The reporter did not provided patient information like initials and age nor the data about the Shingrix vaccine lot number and expiry date. The reporter did consent to follow up.
Severe pain left arm which affected ROM for at least 3 months. Pain continued and progressed to include left side rib pain which continues despite left arm pain resolving after approximately 6 months. Dx: Brachial Neuritis with systemic involvement.
Within 15 minutes of the injection started having lip and tongue swelling - went ER then started having a rash on neck, nausea, headache, difficulty swallowing, mild SOB and coughing
Patient's mother came to the pharmacy clinic intending to get up to date shots for her child for the new school year. The vaccination record booklet was evaluated and it was understood that we were going to be giving the first dose of the COVID vaccine. The mother answered the screening questions all indicating that she had not previously vaccinated her child for COVID. The COVID vaccine was given and then the mother stated that she had gotten a COVID vaccine already at a church clinic on 08/08/2021. It was not until after the shot was given that she informed us of the initial shot and shown the vaccine card.  A language barrier contributed to the miscommunication and the patient and mother went to a PCP visit where they were further evaluated and aware of the early COVID vaccine administration.
Started having symptoms of oncoming shingles attack a day or two after my 2nd Pfizer Covid vaccination. Broke out in severe case of shingles four days after vaccination. (I know the experts have said there is no relation between Covid vaccination and shingles, but I beg to differ. Numerous cases have been reported, just not acknowledged.)
This spontaneous report as received from a healthcare worker, refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 01-APR-2016, the patient was vaccinated with 0.5 ml dose of improperly stored (Merck) VARIVAX (which had a lot # of L040419 and an expiration date of 14-OCT-2017; however, dosage number and route of administration were not reported). Nonetheless, no adverse effects were reported. Another batch of (Merck) VARIVAX (which had a lot # of L043624 and an expiration date of 03-NOV-2017) had also been improperly stored but it was not reported whether it had been administered. The vaccines experienced the following temperature excursions on the following dates: 10 F for 2 hours and 15 minutes on 24-MAR-2016; 12.4 F for 2 hours and 15 minutes on 26-MAR-2016; 10.4 F for 2 hours and 15 minutes on 30-MAR-2016. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Patients states that his normally steady blood pressure and blood glucose have had higher than normal fluctuations with blood pressure being very low and blood glucose being very high. He said this seemed to occur at around time of vaccination and continues to date of this report.
I experienced Covid-19 on October 07, 2022 my symptoms were body aches, fever, cough, congestion. I was prescribed PAXLOVID.
extreme red flushing from mid chest to top of head, severe itching in ears and eyeballs, tingling lips. Fatigue.
I vaccinated the pt who stated he only had a sore arm with the first vaccine and no other reaction and that he had never had any kind of severe reaction to drugs, vaccines, or foods.  Approximately 5-10 minutes after vaccinating Client, I was informed that his top lip was swelling as he sat in our Waiting Area.  I immediately went to check on him and observed visible swelling of the middle of his top lip.  I asked if he had noticed any other swelling, trouble swallowing, or breathing, to which he replied he did not.  I then when to check with the pharmacist running the clinic to verify the best way to proceed.  I was prepared with an Epipen a few feet away from pt to use if needed. Another pharmacist, brought over an ice pack. Pharmacist again questioned the pt who affirmed he had no other symptoms and that the swelling did not appear to be spreading.  We offered to call 911 and the pt declined, insisting that we not make a fuss.  We insisted that we wanted to make sure he did not have any trouble breathing or any other reaction and to sit for 30 minutes of observation.  Pt accepted the ice pack and reluctantly agreed to sit for "a while".  I sat with the pt monitoring him closely for about 30 minutes and engaged him in conversation.  Pt had no issues breathing or speaking and repeatedly stated that it was not itchy or painful and the swelling had receded minimally after 30 minutes.  He experienced no other symptoms, but was tired and wanted to go home,  He explained that he had his colon removed this past Monday and was in some discomfort and was very tired.  The patient was eager to leave and again declined further medical treatment.  I provided the patient with generic benadryl tablets since he he did not have any at home.  I instructed him to go home, take 2 tablets with a big glass of water, and take his nap. I asked if I could call him later this afternoon to follow-up with him and he approved.  I told him that I would report the incident here.  I also told him that if his symptoms worsened and if he had any trouble breathing to call 911.  The patient then left the Waiting Area.
Itch on back; itchy rash starting between shoulder blades then got worse, now on whole back up to shoulder down to the waist; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash starting between shoulder blades then got worse, now on whole back up to shoulder down to the waist) and PRURITUS (Itch on back) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2021, the patient experienced RASH PRURITIC (itchy rash starting between shoulder blades then got worse, now on whole back up to shoulder down to the waist). On an unknown date, the patient experienced PRURITUS (Itch on back). At the time of the report, RASH PRURITIC (itchy rash starting between shoulder blades then got worse, now on whole back up to shoulder down to the waist) and PRURITUS (Itch on back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient had self-medicated with hydrocortisone ointment 2.5 % and a clear anti-itch lotion from a local pharmacy which is unopened and expired. the lotions contained pramoxine HCl 1 % and zinc acetate 0.1 % which was applied at 4 to 5 AM on 17 Jan 2021.; Sender'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. Further information has been requested
rash is on his chest, head, arms and hand.; itching; can't sleep at night; This is a spontaneous report from a contactable consumer (Patient) received from a Pfizer-sponsored program. A 70-years-old male patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on an unspecified date for covid-19 immunisation. On an unspecified date, the patient experienced rash is on his chest, head, arms and hand; itching and can't sleep at night. The patient underwent lab tests and procedures which included Bloodwork: unknown results on 16Mar2021. Therapeutic measures were taken as a result of rash is on his chest, head, arms and hand, itching was Triamcinolone acetonide a lotion for his body and Fluocinolone acetonide an oil for his head and after 1 week and Allegra and other creams were prescribed by dermatologist still itching horribly lasted up to 3 weeks. He asked if his experience have been reported as a side effect to the vaccine. The outcome of the events rash, pruritus was not resolved, and for the event insomnia was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Left arm swelling and redness all around arm.  Warm to touch.  Very sore.
General side effects have included the need to sleep within 2 hours of getting the vaccine. Tiredness, headache, stuffy nose, swollen lymph nodes under right armpit.
Information has been received from a physician concerning an 11 year old female with drug hypersensitivity who on 24-AUG-2007 was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot number "10294"). On 25-AUG-2007, the patient experience significant swelling, warmth and redness at the injection site. Subsequently, the patient recovered from significant swelling, warmth and redness at the injection site. No further information is available.
This non-serious spontaneous case, was initially received from other health professional, concerning a patient of an unspecified age and gender. On an unspecified date in Sep-2017, the patient received AFLURIA QUADRIVALENT (batch number: 00644623A (reported as 644623A), expiry date: Jun-2018, dose, route of administration, anatomical location: not reported). On an unspecified date, the patient experienced mild reactions at the injection site including redness, warmth and slight swelling. The outcome was not reported. The reporter did not provide the seriousness assessment. Non-significant case correction received with IRD 22-Sep-2017: Batch no. (00644623A) was captured in the case form and narrative was amended accordingly.
10 minutes after child received MMR #1, parent noted area of redness. Per provider an area of  6cm redness, 2cm induration, irregular in shape surrounding right anterolateral injection site. No other skin lesions noted. No respiratory distress noted. Per doctor's order, Benadryl 10mg po was given. Parent's of patient instructed to wait 1 hour. Parents instructed on signs of allergic reaction and importance to get medical attention.  Parents refused to wait and left clinic area.
pt recvd vax 20OCT95 & 8NOV95 pt devel approx 10 small red vesicular bumps on face, legs, & back;MD reported felt they were pox lesions;pt subsequently recovered;no further details were provided;
Received 1st dose of vaccine on 1/11. On the morning of 1/12, developed symptoms of fatigue and malaise. Left work at 1300. Reports that later in evening symptoms progressed to body aches and diaphoresis, no fever. Reports feeling better this morning 1/13.
had cardiac monitor which showed PSVT, "muscle in heart not kicking on right; This spontaneous case was reported by a consumer and describes the occurrence of SUPRAVENTRICULAR TACHYCARDIA (had cardiac monitor which showed PSVT, "muscle in heart not kicking on right) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 experienced SUPRAVENTRICULAR TACHYCARDIA (had cardiac monitor which showed PSVT, "muscle in heart not kicking on right). At the time of the report, SUPRAVENTRICULAR TACHYCARDIA (had cardiac monitor which showed PSVT, "muscle in heart not kicking on right) outcome was unknown.            No concomitant medication details was reported. He had heart palpitations for 2 months and no longer has cardiac symptom.  No treatment medication details was reported.  Company comment: This case concerns a male patient of unknown age, with no medical history reported, who experienced the adverse event of special interest of supraventricular tachycardia an unknown time after a dose of mRNA-1273. The patient received dose 1, 2 and 3 with mRNA-1273 vaccine, but it is unclear when the symptoms onset happened. Symptoms, such as heart palpitations, lasted for 2 months and then disappeared. Information regarding clinical evaluation and treatment provided has not been disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-558252 (Patient Link).; Sender's Comments: This case concerns a male patient of unknown age, with no medical history reported, who experienced the adverse event of special interest of supraventricular tachycardia an unknown time after a dose of mRNA-1273. The patient received dose 1, 2 and 3 with mRNA-1273 vaccine, but it is unclear when the symptoms onset happened. Symptoms, such as heart palpitations, lasted for 2 months and then disappeared. Information regarding clinical evaluation and treatment provided has not been disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Both immunizations given in (L) arm on 10/19/2016 at 430 pm. On 10/19/16 530 pm (L) arm swelling and soreness. On 10/19/16 at 730 pm hives and itching (L) arm. Mom calling Dr. for appt today.
Moderna Covid vaccine] treatment under Emergency Use Authorization(EUA): Pt. first reported neck stiffness that 10 min later said she didn't feel right. She was very flushed and blotchy. this was 2nd dose no reaction from the 1st. Time of 2nd vaccination was 10:00 and symptoms started around 12:15.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information was provided regarding patient's pertinent medical history, concurrent condition and concomitant medications. No previous drug reactions or allergies were reported. On 11-AUG-2015, the patient was vaccinated with first dose of RECOMBIVAX HB injection 10 Y (dosing details were not reported) (lot # K012469 with expiry date of 14-APR-2017). The reporter stated that on an unknown date, the patient had reoccurring throat surgeries due to an unspecified throat issues for which the patient was hospitalized on multiple unspecified dates after the administration of the first dose of RECOMBIVAX HB. On 13-APR-2016, the patient received second dose of the RECOMBIVAX HB (lot # L042846 expiry date of 15-SEP-2017) which was delayed due to the surgeries (inappropriate schedule of vaccine administered). The outcome of the events was unknown. The reporter did not provide the causality assessment between the events and the suspect therapy. There was no product quality complaint involved. The events Oropharyngeal surgery and Oropharyngeal discomfort were considered serious due to hospitalization. Additional information has been requested.