chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt began screaming, gasping for breath, approx 3 hrs post/vax. Unable to check temp, due to irritability. R/leg swollen, infant occasionally "jerks". Saw Dr & given Atarax. Pt screamed until 8:00pm, then again at 2:00am, give Atarax again.
AFTER 10 DAYS OF VACCINATION THE PATIENT BEGAN SHOWING SIGNS OF SYMMETRICAL WEAKNESS. RECEIVED PHYSICAL THERAPY, HAD AN MRI. DX ARTHRALGIA IN LEFT SHOULDER.
This case was reported by a consumer via call center representative and described the occurrence of shivering in a elderly male patient who received SHINGRIX for prophylaxis. On 1st October 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shivering, pain and influenza-like symptoms. On an unknown date, the outcome of the shivering, pain and influenza-like symptoms were unknown. It was unknown if the reporter considered the shivering, pain and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the patient's husband. The age at vaccination was not reported. The patient experienced shivering, aches, pain and flu-like symptoms after receiving a dose of SHINGRIX. The reporter got disconnected the call before additional information could be gathered.
pt recv vax 19JUN96 & approx 3wk later pt exp a rash w/30-40 generalized vesicles & a fever;pt father a med physician dx w/chickenpox;pt recovered 1wk later;
PUNCTURED VACCINE VIAL HAS BEEN IN THE FRIDGE FOR MORE THAN 6 HOURS; MEDICATION ERROR; VACCINE WAS  LEFT OVERNIGHT IN THE FRIDGE AND TODAY A DOSE OF THE VACCINE FROM THIS VIAL WAS ADMINISTERED; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. 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, batch number: Unk) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the subject experienced vaccine was left overnight in the fridge and today a dose of the vaccine from this vial was administered. On an unspecified date, the subject experienced punctured vaccine vial has been in the fridge for more than 6 hours, and medication error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the punctured vaccine vial has been in the fridge for more than 6 hours, medication error and vaccine was left overnight in the fridge and today a dose of the vaccine from this vial was administered was not reported. This report was non-serious.
Initial report was received 19 September 2011 from a health care professional which involved a cluster of two patients. The other patient has been captured in case number 2011-08895. A 16-year-old male patient had received an injection of FLUZONE SV 2011-2012, lot number UH467AB on 17 September 2011 (route and site of administration not reported) and on the day of vaccination, the patient developed muscle aches and arm soreness. The patient presented to the emergency room on 19 September 2011 for throat tightness, bilateral wrist pain, facial numbness and bilateral forearm parasthesis. Outcome was not recovered. No additional information was provided at the time of the report. Documents held by sender: None.
Sore throat; Nauseous; Heart palpitations; Fever; Chills; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nauseous) and PALPITATIONS (Heart palpitations) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 24-Feb-2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). On 25-Feb-2021, the patient experienced NAUSEA (Nauseous) and PALPITATIONS (Heart palpitations). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat). At the time of the report, PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever) and CHILLS (Chills) had resolved and NAUSEA (Nauseous), PALPITATIONS (Heart palpitations) and OROPHARYNGEAL PAIN (Sore throat) outcome was unknown.            The concomitant medications were not provided.
LOCALIZED REACTION REDNESS, WARMTH, HALF DOLLAR INDURATION WITH  TENDERNESS, URTICARIA  PATIENT TREATED WITH COLD PRESS, ALEVE, BENEDRYL
large areas of hives on my upper torso and legs beginning at 0800PM on 4/13/2021 and spreading quickly by 0930PM on 04/13/2021.  I took benadryl which seemed to help bring down the hives. When I woke up it had moved to my arms and shoulders and my back and legs had cleared up.
Information has been received from a nurse (clinic coordinator) concerning unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients received doses of improperly stored PNEUMOVAX 23 (lot # L014420 with expiration date 23-FEB-2017, dose and route were not reported). The doses of PNEUMOVAX 23 underwent temperature excursions at 34.8 F for 6 hour 25 minutes and 14.6 F for 5 hours 45 minutes respectively. Previous temperature excursion was as followings: 47 F for 45 min, 48 F for 45 min, 49 F for 30 min, 50 F for 45 min and 50 F for 3 hour 15 min. Data logger was involved. Product quality complaint (PQC) was not involved. Additional information has been requested.
The day after the first vaccination shot, started to get menstrua spotting (currently 4 days and going) after having a menstrual cycle just 2 weeks prior.
Herpes; Dizziness; Palpitation; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), PALPITATIONS (Palpitation) and HERPES VIRUS INFECTION (Herpes) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced DIZZINESS (Dizziness), PALPITATIONS (Palpitation) and HERPES VIRUS INFECTION (Herpes). At the time of the report, DIZZINESS (Dizziness), PALPITATIONS (Palpitation) and HERPES VIRUS INFECTION (Herpes) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information not provided. Treatment information not provided
Extreme itching all over body.  Took two Benadryls to relieve itching.
Information has been received from a nurse practitioner concerning a 65 year old female who previously in October 2006 was diagnosed with a case of shingles who on 17-MAY-2007 was vaccinated with a dose of ZOSTAVAX. On 25-MAY-2007 the patient experienced rash associated with shingles on the left part of her back. Medical attention was sought. The patient recovered from rash associated with shingles on the left part of her back. No product quality complaint was involved. Information to process a specimen for PCR analysis was sent to the physician. Additional information has been requested.
Severe pain due to very red rash from top of the shoulder to my elbow; hot to touch and very itchy
Area of induration (3 x 4 cm) and erythema (6 x 5 cm) on upper right arm.  Area blanching minimally tender but tense.  Full range of motion of shoulder/elbow.
No reaction at first. Then, approximately 2 weeks later began with inflammation and heat, sore to the touch. Starting to hurt not touching it.
Patient stated, "It feels like I have bricks on my chest".  Expiratory wheezing noted on auscultation. Patient uses an albuterol inhaler as needed due to being in the process for evaluation of asthma. Patient stated that she was not short of breath prior to the vaccine. Onset of shortness of breath and wheezing noted within 5 mins of receiving the vaccine. EMS called and patient transported to the ER for further evaluation.
This spontaneous report as received from a Registered Nurse, refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 (which had a lot # L040456 and expiration date of 10-MAY-2107; however, dosage number and route of administrations were not reported). Nonetheless, no adverse effects were reported and no product quality complaint was involved. Additional information has been requested.
fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer).  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2, for COVID-19 immunisation, reaction(s): "mild twinge of soreness in her arm". The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "fatigue".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever 102 F; Headache; Ear ringing; Itching scalp, tongue, lips and hands; Fatigue; Dizziness; Vaccine site pain; This is a spontaneous report received from a contactable consumer (patient) via a regulatory authority.   A 44-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 left arm on 08Apr2021 at 09:45 (at the age of 44-year-old), as a single dose for COVID-19 immunization. Medical history included a history of allergies to seafood, chocolate, oat and avocado. Concomitant medications included doxycycline (ORACEA) from an unknown date and for an unspecified indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 08Apr2021 at 09:45, the patient experienced fever 102 degrees Fahrenheit, headache, ear ringing, itching scalp, tongue, lips and hands, fatigue, dizziness and vaccine site pain. Symptoms lasted for a period of 24 hours. On 09Apr2021, the patient underwent lab test and procedures which included PCR COVID (Nasal swab) test and the results were found to be negative and on 08Apr2021 at 09:45, the patient underwent body temperature test and the result was 102 degrees Fahrenheit. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as the result of adverse events. The clinical outcome of fever 102 F, headache, ear ringing, itching scalp, tongue, lips and hands, fatigue, dizziness and vaccine site pain were recovered on 09Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Flu; Initial information received on 26-Oct-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case involves an adult patient with an unknown demographics who experienced flu (influenza), while he/she received Influenza Vaccine.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, (Unknown latency) it was reported that the very first one back in 1978, worst case of flu (influenza) patient ever had, following the administration of Influenza Vaccine.  Details of laboratory data were not reported.  Action taken was not applicable.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.   There will be no information available on batch number for this case.
Pt recvd vax & 72 hrs later devel tachycardia, palpitations, dizziness, weakness, arm & shoulder pain; pt was prescribed inderal by another MD but discontinued the medication because of the way it made pt feel; pt does have sinus tachycard
Patient fainted after influenza vaccine administered. Her head hit table and then she "woke up".
Hives, diffuse full Body  Tongue Swelling  SoRe thRoat
This spontaneous report was received from a female patient of unknown age. No information regarding the patient's medical history was provided. On an unkown date in 2011 (reported as "three years ago") the patient was vaccinated with ZOSTAVAX. Dose and route were not provided. No concomitant medication was reported. Since the vaccination the patient had shingles twice (no dates provided) which she considered to be "rare". No outcome was reported. No causality assessment was provided. Additional information has been requested.
The pt experienced a rash with a small red slightly raised bumps to face, trunk, upper and lower ext. Mostly on back. Denies fever or obvious pruritis.
This case was received from a physician on 21 July 2008.  A 20-year-old female patient with a history of aplastic anemia received an injection of MENACTRA in 2005 (lot number, route/site, and date of administration not reported).  According to the reporter, the patient was "recently" diagnosed with meningitis, serogroup Y.  The patient was taking cyclosporines at the time of the event.  Outcome was reported as recovered.  No other information was provided. 10/27/08-records received for DOS 6/9-6/9/08-DC DX: Meningococcemia with presumptive Neisseria meningitis. Presented to ER after a 1 day history of fatigue fever and chills. Felt dizzy and was febrile. C/O severe and generalized body aches, headache. Began menses that morning. Sepsis with tachycardia, elevated temperature subsequently became hypotensive, hemolysis with hemoglobin dropping to 7.5 from 10.7. On 8th day C/O pleuritic type chest pain and hypoxic. Syncope likely secondary to antibiotic reaction to Amoxicillin. No lumbar puncture performed.
Pain and significant erythema, induration and warmth three days following injection that was 7-8 inches in diameter
Oral temperature recorded at 103.5 at home on repeated measures.  Irritability.
12/29-1/2 Flu like symptoms with hardly a fever and fatigue. Took a CoVid test(antigen abbot binexNOW) and found to be positive. Work quarantined me and I drank plenty of fluids. Took Aleve and rested until 1/8. On Tuesday 1/11, took another CoVid antigen test and returned positive and was welcomed back to work.
Dizziness & Headache  Narrative: referred to PCP if sx worsen or persist
Case number PHEH2012US024924 is an initial spontaneous report received from a nurse on 14 Dec 2012: This case refers to a 17-years-old male patient. He was received only Men C,Y,W-135 liquid conjugate component of MENVEO vaccine (batch number: M12009), intramuscularly without being reconstituted with Men A component on 12 Dec 2012. No adverse reaction reported following this administration error.
Nausea, headache x 3 days. Became ill the night I received vaccine. Received vacc. 12/13/10. Red bump at injection site. Small the size of approx 0.2cm diam.
Headache & NauseaVomiting Narrative:  Body aches and fatigue.
People who have gotten the flue from shot and got it real bad; People who have gotten the flue from shot and got it real bad; Initial information regarding an unsolicited valid non-serious case received from a consumer via social media in on 19-Oct-2020.  This case is linked to case 2020SA295897 (cluster).  This case involves a patient of unknown demographics who had gotten the flue from shot and got it real bad (influenza) and (feeling abnormal), while the patient received vaccine Influenza Vaccine.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, the reporter stated that who had gotten the flue from shot and got it real bad (influenza) and (feeling abnormal).   It was not reported if the patient received a corrective treatment.  Outcome of both the events were unknown, at the time of reporting.  Information on the batch number was requested.      The reporter assessed the causal relationship with suspect vaccine as related.
This spontaneous report as received from a registered nurse refers to a 12 month old patient. On 12-AUG-2013 the patient was vaccinated with a dose of 0.5 ml PNEUMOVAX23 (lot# not reported) subcutaneous. No adverse effects reported. Additional information has been requested.
shingles; This initial spontaneous report has been received from a lawyer regarding a case in litigation and refers to a currently 72 years old female patient. No information was provided regarding medical history, concurrent conditions or concomitant medications.     On or about 02-NOV-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, dose#, route, batch/lot# and expiration date were unknown) for the long-term prevention of shingles and zoster-related conditions.       On an unknown date, the patient experienced shingles. On an unknown date, the patient was treated by a healthcare provider for shingles. The outcome of the event of shingles was not reported. The reporter considered the event to be related to Zoster Vaccine Live (ZOSTAVAX).
Right knee (joint) pain. Some upper calf (maybe muscular) some lower thigh (maybe muscular) also right leg. Possibly residual joint pain. Dull ache.
Patient reported that after a couple of hours of receiving the covid vaccine, she became dizzy, nauseated,  and lightheaded. She reported her blood pressure was low 80/60 and her heart rate about 100. She rested and her pressure came up. Then she reported a couple hours later she felt that way again while walking around house. She sat down and felt better. Then around 6p symptoms came back and she also had a headache and a little shortness of breath.  She then decided to go to the ER.
rash on upper lip; blisters on upper lip; lip was swollen; lip was red; This case was reported by a physician via call center representative and described the occurrence of rash lips in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC).   On 26th October 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In October 2021, 48 hrs after receiving Shingrix, the patient experienced rash lips, lip blister, lip swelling and lip redness. On an unknown date, the outcome of the rash lips and lip blister were recovered/resolved and the outcome of the lip swelling and lip redness were not recovered/not resolved.   It was unknown if the reporter considered the rash lips, lip blister, lip swelling and lip redness to be related to Shingrix.  Additional details were provided are as follows: The case was reported physician on behalf of the patient. The patient received a dose of Shingrix and within 48 hours patient had developed blisters/rash on upper lip and upper lip was red and swollen. The blisters/rash had resolved but the patient's upper lip was still red and swollen.   The patient had received Zyrtec as concomitant. Spoke per PI that rash could be a hypersensitivity reaction.  Sent copy of PI per health care professional request.   No lot or expiration date was known as vaccine was given at the pharmacy. The reporter consented to follow-up.
I had my vaccine the day before I expected my period. My period ended up being over a week late and I barely bled. My cycle has been incredibly regular my entire life, except for when I was in hormonal birth control, which I stopped taking well in advance of my vaccine. I took multiple pregnancy tests to confirm that my lateness was not a pregnancy, all of which were negative.
No adverse effects; one dose of improperly stored ROTATEQ  was inadverently administered; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 05-NOV-2019, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (strength, formulation, dose/frequency were not reported) (lot# 1658256, expiry date: 18-NOV-2020) for prophylaxis. On 05-NOV-2019, one dose of improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) was inadvertently administered to the patient (product storage error). The vaccine was stored at a temperature of above 9.4 Celsius. There was no previous temperature excursion. The call was because of data logger. No adverse effect was reported. The outcome of product storage error and no adverse event was unknown.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA003116: US-009507513-1911USA003130: US-009507513-1911USA002735: US-009507513-1911USA002713:
Rash; This spontaneous case was reported by a physician and describes the occurrence of RASH (Rash) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced RASH (Rash). At the time of the report, RASH (Rash) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication use was not provided.  Treatment information was not reported.   This case was linked to MOD-2021-348460 (Patient Link).
Topical Rash developed at site 7 minutes post injection.  VS stable.  Medical Director consulted.  Will monitor for additional 15 minutes.  No additional symptoms.  Released home -no intervention.
This spontaneous report as received from a nurse practitioner refers to a female patient of an unknown age, who was nursing. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not reported. The reporter was calling to inquire about recommendations for the administration of GARDASIL 9 (dose, route of administration, lot# and expiry date were not reported) to a patient, who was nursing. The patient was not in the office at the time of report. No product quality complaint (PQC) was involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
I experienced acute vertigo and nausea three days after vaccine. I was treated at the ER at Hospital on Wed. 3/17/21, and discharged on 3/19/21. The diagnosis was Unilateral Vestibular Hypofunction; it was the same side I got the shot on (left). I was treated with meclizine and given outpatient eye-hand exercises to do. The symptoms have faded, but not disappeared as of today, 3/20/21.