chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a licensed practical nurse concerning a 69 year old male with a history of high cholesterol who on 26-DEC-2006 was vaccinated with the first dose of Pneumovax 23 (lot #655152/0889F), 0.5 mL, IM in the left deltoid.  Concomitant therapy included niacin.  On 28-DEC-2006, the patient presented to the physician's office with cellulitis at the injection site which included redness and swelling after receiving Pneumovax 23 on 26-DEC-2006.  The patient was treated with antibiotics (cephalexin).  On an unspecified date, the patient recovered from the cellulitis at the injection site.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements of the agency and was released.  Additional information is not expected.
Itchy Body wide Rash less than 24 hours after vaccine Administration. Benadryl 25mg orally given every 6-8 hours. Loratidine given once daily x3 days Prednisone 50mg orally 10/22/19 then daily x4 more days.
Initial unsolicited report received from a non-healthcare professional (consumer) on 07 August 2015. A patient (age and gender not reported), whose medical history and concomitant medications were not reported, had received dose of MENACTRA (batch number, expiry date, route and site of administration not reported) on an unspecified date. On an unknown date, few days after the vaccination, the patient was acting funny and then at five days post vaccination developed convulsions and seizure type behavior. The patient was taken to the hospital (dates not specified). Laboratory investigations and corrective treatments were not reported. At the time of this report the outcome of the events was not reported. Documents held by sender: none.
A non-serious report of administration of expired FluMist has been received from a nurse concerning a seven-year-old male.  Neither medical history nor concomitant medications were provided.  The patient received FluMist on 12-Mar-2008.  The FluMist had expired on 10-Mar-2008.  The reporter stated that she received 100 doses of FluMist from the Vaccines For Children Program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008.  The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients.  The patient had no adverse events at the time the report was received, neither as of 18-Apr-2008 when the office was contacted for follow-up information.  The event has resolved.  It was not reported whether or not FluMist was re-administered.  The reporter provided no causality assessment for the event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.  Follow-up information received 18-Apr-2008 and incorporated into the narrative: no adverse event occurred.  This case is linked to the following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006659; MEDI-0006670; MEDI-0006671; MEDI-0006672; MEDI-0006673; MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684.
Tested positive for Covid after receiving first dose Vaccine; Tested positive for Covid after receiving first dose Vaccine; This is a spontaneous report received from a contactable consumer (reporting on herself). A 48-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: ER8732 and Expiration Date was not reported), via an unspecified route of administration in Arm Left on 25Mar2021 as single dose for COVID-19 immunization. Medical history included type 2 diabetes mellitus from 2013 and ongoing. Family Medical History: No, caller does not think so, sickle cell trait, but not a big deal. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that she received the first dose BNT162B2 on 25Mar2021, patient clarifies she was in the Emergency room last (Friday) on 09Apr2021 and tested positive for covid 19. Patient asking do i need to change the date of her second covid vaccine. Patient tested positive for covid after receiving first dose vaccine. she doesn't feel sick, doesn't feel very sick, not that bad. Patient was scheduled for second dose BNT162B2 on 22Apr2021 and wants to find out if it was okay to go ahead and received the second dose BNT162B2. People was telling patient so many different stories and she doesn't want to hear it, patient wants to hear it from the people who produced the vaccine. Patient states she works with children who have autism, was a first contact essential worker. Patient reports she was tested for Covid Virus on 09Apr2021 and the results were given to the caller of a positive Covid test on 10Apr2021, patient was unsure which was for diagnosis date. Patient was an essential worker, working with kids and most of the workers think it is good to prevent the kids instead of coming to work, most of the kids have medical issues. Those are the two reasons. Patient reports started taking Tylenol when started feeling sick, not be-fore and not immediately after. Took two 500mg Extra strength Acetaminophen every 8 hours. Patient reports the thing was, patient wasn't really feeling well. Patient had all those chills and everything and thought a side effect and kept taking the Acetaminophen for about 6 days. The fever wasn't going down, patinet felt funny in the throat and chest, this was how the caller ended up in the emergency room. Clarifies felt funny in the upper part of the chest. Patient reports taking the Tylenol after feeling sick, not after the vaccination. The outcome of the events was unknown.
This dose of the Pfizer COVID-19 vaccine was administered to a 10y/o patient on 11/15/2021. The dose that was administered to the patient was of the 12y/o+ Pfizer formulation (purple cap). This was brought to our attention when the Department of Public Health sent a Immunization Registry (IR) line listing for this dose to our staff via email. The dose was entered under our organization's ID. DPH acknowledged that the lot number that was administered was of the 12y/o+ Pfizer formulation, but the patient was 10 y/o at the time of vaccination. We assessed our records and confirmed that this was the case. We reviewed CDC recommendations for an event of this nature and noticed that the recommendation is for the patient to receive their second as the 5y/o to 11y/o formulation at the regular 21-day interval. Per IR records, the patient received their second dose as the 5y/o to 11y/o formulation on 12/10/2021 at a different facility. Our staff contacted the patient's family yesterday and notified them of the error. The patient's family stated that the patient experienced normal side effects (headache, generalized body aches, injection site soreness) after the first dose, but these symptoms resolved after a few days. The patient is not currently experiencing any symptoms related to this event, but the patient's family was advised to follow up with the patient's primary healthcare provider in the event that any concerns develop in the future.
Patient was hospitalized Oct. 25, 2021 for possible demyelinating neuropathy of lower extremities following a positive COVID-19 test on 10/13/21. This is classified as a breakthrough case.
This case was reported by a consumer via call center representative and described the occurrence of shingles in a patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The reporter stated that he wanted to receive the SHINGRIX vaccine and looked for a provider all over. The reporter found a provider who stated that they administered 40 doses thus far. Within a week and half of vaccination, the patient experienced shingles. The case of Shingles was moderate. The consumer stated that the provider informed him that they submitted these adverse events to GlaxoSmithKline. This case has been linked with case US2018056979, reported by the same reporter.
Arm from the site of the injection to almost the elbow, read, swollen and very hot to the touch and sore. I iced the area for about an hour. Today it is still red but the swelling is down and a little tend er to the touch but much better. Did not have to call my doctor.
pt recv vax;had fever/ chills;14aug95 arm sore;15aug95 local redness/warmth around inject site;instructed to take dph;
INCREASE HEART RATE; HEADACHE; NAUSEA; TIREDNESS; FEVER; 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, intramuscular, batch number: Unknown) dose was not reported, administered on 05-MAR-2021 to Left Deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 05-MAR-2021, the subject experienced headache. On 05-MAR-2021, the subject experienced nausea. On 05-MAR-2021, the subject experienced tiredness. On 05-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced increase heart rate. Laboratory data included: Heart rate (NR: not provided) increased. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, nausea, tiredness, and fever on 06-MAR-2021, and had not recovered from increase heart rate. This report was non-serious.; Sender's Comments: : V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Pt received vaccines 12/31/18. 1 week after administration mom noted red area with lump to left upper lateral thigh. In office for assessment 01/10/19. Noting red area 1 x 3 cm, hard knot, slight warmth to skin. No blisters or open areas noted. Mom denies bothering pt. Mom denies pt bothering area.  Treatment is observation.
Lost muscle function; Fell; This non-serious case was reported by a consumer via call center representative and described the occurrence of muscle weakness in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In NOV-2022, the patient received the 2nd dose of Shingrix. In NOV-2022, less than a day after receiving Shingrix, the patient experienced muscle weakness (Verbatim: Lost muscle function) and fall (Verbatim: Fell). The outcome of the muscle weakness and fall were resolved.   It was unknown if the reporter considered the muscle weakness and fall to be related to Shingrix.     It was unknown if the company considered the muscle weakness and fall to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-APR-2023 The patient received 2nd dose of Shingrix and on the same day he lost muscle function and fell. The event lasted minutes and recovered.  No other information provided.  The reporter consented to follow up. This case had been linked with US2023062498, reported by same reporter.; Sender's Comments:  US-GSK-US2023062498:Same reporter.
terrible gas and bloating - starting 12 hours after injection and lasting 1 day,  rapid and irregular heart rhythm - beginning 40 hours after injection - lasting 6 hours, extreme tiredness - day 7 & 8, lower back and hip pain - day 7 and currently day 10, general feeling unwell - most days
This spontaneous report was received from a physician via company representative refers to a 62 year old female patient. No pertinent medical history was reported. Last Tuesday on an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route, lot # were not reported). Within two days on an unknown date, the patient contacted the office to report that she had what she believed was a Shingles like rash starting from two inches from the injection site distributed down to her elbow. The patient reported that the area was painful, burning and she experienced malaise. The physician had not seen the patient in the office and cannot confirmed this was a case of Shingles. Office visit was pending. The physician had only prescribed that the patient could take BENADRYL and ibuprofen or TYLENOL (dosages unknown) if she develops fever, until she visits the office and the diagnosis is confirmed. Action taken was not applicable. The outcome of events was unknown. Causality was not assessed by the reporter. Additional information has been requested.
first, let me say I do not know if my problem definetly occured due to the Flu shot I received.  Until receiving this years Flu shot I had never before participated in the Flu vaccination program.  Approx. 3 weeks after the shot was administered I contracted ITP. Idiopathic Thrombocytopenic Purpura. My blood platelets were found to be extremely low. According to the Dr. they were at 4000. I spent 3 days in hospital until the Platelets were brought back up to normal capacity. One month prior to receiving the Flu shot my blood platelet count was at 230,000. While in the hospital, Gamma Globulin and Steroids were used to as treatment.                    Have asked Doctor to provide:  1. Name of Vaccine 2. Manufacturer 3. Lot Number 4. Date Flu shot given. The discharge summary received on 3/23/04 states bruises and purpura.
Patient reports getting a rash after their first dose of Moderna 8 days after injection. Patient reports redness at site of injection, warm, raised, no itching, but lasted for 1 week then resolved. Patient self treated at home and took ibuprofen and zyrtec.
Patient developed vomiting and headache on 9/29/2021 around 2:30 am which subsided gradually. He developed chest pain On 9/30/2021 at night and therefore went to ED on 10/1/2021 AM. He was transferred to another hospital on 10/1/2021 and patient was admitted to cardiology service for observation. He was discharged on 10/2/2021 as he found to have no chest pain and was stable.
stuffy nose; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) via an unspecified route of administration on 31Dec2020 at single dose for Covid-19 immunization. Medical history included exposed prior to the vaccine. Concomitant medications were not reported. The patient informed that she got the vaccine on 31Dec2020 and was recently told she had been exposed prior to the vaccine. The patient currently has a stuffy nose and was wondering if she should get tested. The outcome of the event stuffy nose was unknown.
High fever - 101 degrees (my base line body temperature is generally very low, usually 96.8 - 97.4) Chills; Extreme Fatigue; Body aches and pains.
New onset Raynaud?s hands and feet.  Picture taken 1/2/21 (9 days after 1st dose), but started noting Raynaud?s in toes a few days prior to that.  Continue to have intermittent Raynaud?s in hands even now, 4 months later.  I am the patient and a physician.  Otherwise healthy, non-smoker, no personal or family h/o Raynaud?s, auto immune d/o or rheumatological d/o.
Acute ischemic stroke - neurologist recommendations was to give TPA.  Post TPA her symptoms significantly improve.  Hospital admission within 6 weeks of receiving the COVID vaccine.
Information has been received on 06-JUN-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 31-MAY-2016, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 28-JUL-2016, the patient was treated by a physician at a primary care practice for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. The patient has been prescribed valacyclovir for management of her painful symptoms. As a direct and proximate result of the ZOSTAVAX and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient has suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Had vaccines on 1/2/02 and that night, had episode of choking-type noises, jerking, pallor, unresponsiveness lasting about 2 minutes followed by sleepiness and then was ok. Similar episode but briefly occurred on 1/7 and 1/12. No other symptoms.
received her 1st Shingrix vaccination / on 09/22/2020 / has not received her 2nd Shingrix vaccination as of today 04/08/2021; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 22nd September 2020, in left arm).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional case details were reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting the patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination. The patient did not know lot or expiration date of drug.  The patient had a question if she could still receive 2nd dose late and would planning on getting her 2nd vaccination on day of reporting.  The patient did not provide reason why she was late with second dose. The VAERS information was reported for 1st dose of vaccine. The permission to follow up was denied.
Within 5 minutes of receiving shot and seated in waiting area patient said his heart began to race and pain was in his upper arm and shoulders. He felt weak. He started trying to catch his breath.
I had this vaccine six weeks ago and now have limited mobility in my left shoulder. The place I got the shot in my arm is still a little tender but the main problem is my sore shoulder. Hard to raise my arm. Hard to change clothes.
Headache; Sore arm at injection site; Body ache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (Headache), VACCINATION SITE PAIN (Sore arm at injection site) and MYALGIA (Body ache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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 HEADACHE (Headache), VACCINATION SITE PAIN (Sore arm at injection site) and MYALGIA (Body ache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. At the time of the report, HEADACHE (Headache) had not resolved and VACCINATION SITE PAIN (Sore arm at injection site) and MYALGIA (Body ache) had resolved.            Concomitant medications was not provided by the reporter.
Fussy after shot. Drank only 8 oz of milk since 3:00pm after shot. Fever of 101.1 on 1/3/11 at night. Gave TYLENOL temp dropped to 99 that night but rose to 102 by morning of 1-4-11. Kept using TYLENOL. Thought daughter might have cold since daughter was choking on milk. Sounded like cold per mom.
covid-19; covid-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2020 as dose 1, single (Lot number: EK5730), on 13Jun2021 as dose 2, single (Lot number: EL3248) and on 27Oct2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 37 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Acne" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient received vaccine and other medication in 2 weeks. The patient received Anti-viral from 13May2022 to 17May2022, Indication: Treatment of COVID-19. The Adverse event: Covid symptom recurrence, occurred on: 20May2022 at  08:00 AM, Ae resulted in: [None of the above],  If patient recovered: Not recovered, If treatment ae: No.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on reported information, causal association of event drug ineffective, covid-19 with BNT162b2 cannot be excluded. However, response to vaccine can vary in individuals.
7-30-07 erythema and inflammation noted on left arm from deltoid to just above elbow. Warm to touch. Vaccines were given on 7-27-07
dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizzy). At the time of the report, DIZZINESS (dizzy) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: negative (Negative) Negative.         Patient was taking blood presser medication. No Treatment medications were provided.  Patient was taken other test all came back negative.   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Follow up contains no new information
It was reported that a female pt received a Rabies Imovax vaccination on 4/27/01. Reportedly, on 5/4/01, the pt developed generalized hives. Physician evaluated the pt in the ER. Treatment of steroids and Benadryl was given. Per the pt, the symptoms are unresolved.
pt recv vax 29DEC98 & on 1JAN97 pt had fever & sz like activity;pt w/nl physical exam on 2JAN97 & nl Ct Scan that day too;sz activity happened again;
Child developed rash on chest that he was scratching at. Mother reported he had a similar rash on face before vaccines were given. No trouble breathing, hives, or any other allergic reaction. No treatment given.
12/1/2009 mat. grandma reports low grade temp, c/o headache and stomach ache on 11/25/09. Child less active x 2- 3 days. No temp after day 1 post vaccination.