chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 27-Nov-2018 regarding an unsolicited valid non-serious case received from a non-healthcare professional. This case involves a patient of an unknown demographics who had been re-vaccinated with a POLIOMYELITIS VACCINE (INACTIVATED) produced by unknown manufacturer lot number not reported via unknown route in unknown administration site on 26-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to extra dose administered. It was reported that patient had been re-vaccinated with a polio vaccine today 26-Nov-2018 that was deemed stable. It was not reported if the patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Pain, redness and swelling at the injection site for a period of 5 days. The redness was approximately the size of a tennis ball. It was accompanied by muscle aches, nausea, fatigue and headache.
Increasing weakness, fatigue and shortness of breath. Went to MD. Lungs clear, no wheezing, pulse ox sats 95-100%. Nothing made sense, blood work done. Diagnosis autoimmune hemolytic anemia and ITP triggered by vaccine.
Patient received Moderna Covid-19 vaccine that underwent a temperature excursion; Patient received Moderna Covid-19 vaccine that underwent a temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014B22A, 066F21A, 006B21A and 022M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that, the nurse had discovered 2 temperature excursions of the Moderna COVID-19 vaccine for two different lot numbers of the Moderna COVID-19 vaccine. The temperature in the refrigerator that the Moderna COVID-19 vaccine reached 13.1 degrees Celsius on 28-Jun-2022. On 19-Jul-2022, the vaccine reached a temperature of 9 degrees Celsius. Further nurse stated that, none of the vaccine in the refrigerator underwent two different temperature excursions.  Later, the patient received Moderna COVID-19 vaccine that underwent a temperature excursion. The temperature excursion was not known of at the time of administration of the vaccine. The temperature excursion was found out about after a review of the temperature datalogger on the refrigerator that the Moderna COVID-19 vaccine was stored in. The nurse had used the online temperature excursion tool and was comfortable that her patient's doses were valid and that the affected vaccine was viable for future doses.  It was unknown if patient had side effects after any dose.  No treatment medications were reported.
The patient stated on their immunization consent form that they were 66 years old when they received the fluad, though the next day the patient came in for another vaccine and on his consent from it stated he was 56 years old. The patient stated they were embarrassed that they forgot how old they were.
Patient reported experiencing fever, chills and headache after 6 hours of getting the vaccine. He said it all subsided at 3am on 1/5 and is feeling better.
NO CURRENT ADVERSE EFFECTS. REPORT IS BEING DONE AS A PRECAUTION. Patient denied current pregnancy at the time of her vaccinations. She is with only one vaccination session of Td, MMR and Flu vaccine. LMP 10.15.2017. 2 weeks prior to vaccination. EDC estimated to be 07.21.2018. No illness noted after vaccinations. She has a theoretical risk of fetal anomaly as she was given MMR in very early pregnancy.
Sore throat; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in left arm on 10Apr2021 at 08:30 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included high blood pressure. The patient had no known allergies. The concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in right arm on 20Mar2021 at 08:30 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 10Apr2021 at 14:00, the patient had experienced sore throat. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. No therapeutic measures were taken as a result of reported event. The clinical outcome of the event sore throat was not recovered at the time of report.   No follow-up attempts are needed. Information about lot\batch number cannot be obtained.
Patient felt lightheaded immediately after vaccination.  Escorted to the post-vaccination waiting area.  Mild inspiratory and expiratory wheeze on auscultation of lung sounds.  No acute distress.  Offered Powerade drink, patient declined.  Patient recovered by 10:40 and was released.
fever; myalgia; skin reaction; This case was reported by a physician via call center representative and described the occurrence of fever in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, less than a day after receiving Bexsero, the patient experienced fever, myalgia and skin reaction. On an unknown date, the outcome of the fever, myalgia and skin reaction were unknown.   It was unknown if the reporter considered the fever, myalgia and skin reaction to be related to Bexsero.  Additional details were as follows: The age at vaccination was not reported. No patient's identifiers provided. no lot number nor expiration date provided. Physician reported that one patient experienced fever, myalgia and a skin reaction within hours after receiving the first dose of Bexsero. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020211101:same reporter
10 days after receiving the vaccination, child developed a fever of 104, which lasted about 24 hours. Once the fever broke, she began to develop a rash on her face that then spread throughout her body. She had diarrhea for a week, along with the rash, that also lasted for a week and her skin seemed enflamed and sensitive to the touch. I brought her into the doctor with concerns for the rash/fever/gastro problem and they said they had "no way to know if this was caused by the vaccine", even though the materials described her symptoms to the exact nature and timeline.
Very tired about an hour after the shot,  Migraine woke me up a little after midnight, and then had a fever up to 102 and chills the rest of the 9th.   I just rested on the 9th and by the 10th  I was feeling better.
Patient received Fluzone high dose based on the information entered in the profile (69yo). Patient came back about 10 minutes later saying that he was not 69yo but 59yo and because he received high dose he started getting dizzy. The pharmacist called the patient about an hour later and when asked, the patient said he was doing better. The pharmacist was unable to contact the patient the following day.
Rash not limited to injection site. Diffuse swelling and erythema Left upper arm.
Paint to back and leg - Showered blood clots - result hospitalization with continuous heparin drip - daily thrombectomy- stents placed - on Xarelto for lifetime
Information has been received from a RN concerning a 30 year old white male systems analyst with no medical Hx or know of any allergies who, on 04/07/04 was vaccinated IM in the deltoid with the first dose of varicella virus vaccine, live. There was no concomitant therapy or other vaccinations given on that same day. There was no illness at the time of vaccination. The NP reported that on the morning of 04/28/04- The pt developed a 20 pox rash on his torso, legs, and arms. There was a little focal itching , but no fever. Unspecified medical atterntion was sought and a serum varicella zoster virus antibody test was Negative.  At that time the pt's pox were mostly crusted. On 05/03/05, the pt recovered.
Received the 2nd shot at 8am and at 11pm was feeling chills, woke up with low grad temp (99-100.?), tired, achy body, severe headache and pain and redness at injection site. Chills, headache, body aches and temp all went away by end of the day. The redness  at the injection site keeps spreading down my arm and it somewhat itchy sometimes. It's now been the 3rd day and the rash keeps spreading. I have a call into my doctor to discuss.
I developed a itchy rash on my arm where the injection was. There is a bump and it appears red and is warm. It is also painful. It has worsened over the day.
Little lumps at site of injection; It is also red; site on injection has rash; itchiness at the site of injection; This spontaneous report was received from consumer on 25-JAN-2021, concerning a 58 year old male patient who was administered Moderna COVID-19 vaccine9( mRNA-1273). The patient experienced some itchiness at the site of injection, the site on injection has rash and little lumps and it is also red. The patient's medical history was not provided and Concomitant  medication was not provided. The patient received suspect product  mRNA-1273 on 17/Jan/2021, prior to the onset event, the patient received their first dose of mRNA-1273 (lot number:026L20A)  intramuscularly  for prophylaxis of COVID-19 infection  Patient stated that she received her 1st dose of the Moderna COVID 19 on Jan. 17, 2020 through the local department of health. On Jan 24, she started experiencing some itchiness at the site of injection. Today Jan. 25, the site on injection has rash and little lumps and it is also red. She called her healthcare provider and she was told it is expected. She has not taken anything to alleviate the symptoms. Action taken with the second dose of mRNA-1273  in response to the event was not reported
Painful lump at the injection site starting 8/6/17 until present (8/22/17).
Constant Tingling and prickling started in feet and legs on Saturday October 16th, then October 18th moved to hands and arms, now it has moved to face and head on October 26th.  I have now since been having some pain in arms along with it. Cramping in arms and legs as well.
This spontaneous report as received from a physician refers to a 4 month old patient of unknown gender. On an unknown date the patient was inadvertently vaccinated with M-M-R II (lot number not reported), (Merck) VARIVAX (lot number not reported) and VAQTA (lot number not reported). No adverse event was reported. Additional information has been requested.
This spontaneous report as received from a pharmacist via field representative refers to a male patient of unknown age. On an unknown date approximately in April 2013 the patient was vaccinated with a dose of PNEUMOVAX23 dose 1 (lot#, expiry date and dosage not provided). On 07-JAN-2014 the patient received a second dose of PNEUMOVAX23, no adverse effects reported. No product quality complaint (PQC) involved. Additional information has been requested.
Not sure if the vaccine caused this but I noticed my period changed. I would have spotting around the second or third week of my period every month. My doctor would change the birth control but the same issue occurred. I stopped taking the pill in April of 2022 and it took 11 months to get my period back.
No adverse event; I got my bivalent booster a couple of weeks ago. I was inadvertently given the Moderna monovalent.; This spontaneous case was reported by a patient and describes the occurrence of WRONG PRODUCT ADMINISTERED (I got my bivalent booster a couple of weeks ago. I was inadvertently given the Moderna monovalent.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In September 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2022, the patient experienced WRONG PRODUCT ADMINISTERED (I got my bivalent booster a couple of weeks ago. I was inadvertently given the moderna monovalent.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (I got my bivalent booster a couple of weeks ago. I was inadvertently given the moderna monovalent.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.       No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Skin-left arm, erythema, warmth, redness, down to elbow and circumferentially around arm + excoriation on left arm.
Reports sporadic burning sensation upon inspiration and left leg weakness that started morning after vaccination. Had with first Pfizer dose and symptoms resolved in one week.
This spontaneous report was received from a healthcare worker (also reported as office manager) refers to multiple unspecified patients of unknown demographics. No relevant medical history of the patients was reported. On unspecified dates the multiple unspecified patients were vaccinated with (Oka/Merck) VARIVAX (strength, dose, route, site of administration and lot number were not reported). There were no concomitant medications reported. It ws reported that the multiple unspecified patients were administered with (Oka/Merck) VARIVAX that was stored improperly on unknown dates. There were no adverse effects reported.  It was unspecified whether the patient had sought any medical attention. There was  no product quality complaint involved.   Follow up information has been received from office manager, who stated she may call back for fax information as it become available. Also , reported that M-M-R II was not mentioned int he original call, but did experience a temperature excursion. No further information was available at that time.   Follow up information as received from office manager refers to a 15 months  old patient. On 09-JUN-2014 the patient was vaccinated with a dose of improperly   stored M-M-R II (lot # J012818, expiration date 18-OCT-2015) (strength, dose, route and site of administration were not reported). This is one of several reports from the same source. Additional information has been requested.
Patient received the vaccine and the next day experienced typical side effect symptoms (fever, swollen arm, fatigue). Today 3/26/21 she was very sore and tender in the neck area on the opposite side which is left side. She stated that she used theragun to massage the area and noticed in the mirror a golf size ball on her neck. Possibly a swollen lymph node. She reports this swelling is getting worse. Counseled patient to contact MD for evaluation and report symptoms to VSAFE.
Shortness of breath, extreme paleness, rapid heartbeat, dizziness. I took him to the fire truck in the parking lot where he received oxygen for about 10 minutes.
Received flu vaccine Monday 10/2, 24 hours after, itchy on back, stomach and chest. Positive URI sx. Low grade fever. Treatment: Reassurance, claritin and Tylenol.
1st shot: March 1, red body rash appeared about 2:15 a.m. on March 8. Itching and burning. Applied anti-itch cream and went to bed. Gone when I woke up. 2nd shot: March 29, red body rash appeared abut 2:15 a.m. again on April 5th. Not quite as bed. Applied cream, went to bed, gone in the morning. April 16, 2:20 a.m., woke up with severe itching and  burning and discovered the rash came back worse than ever. Very red, knees and top of feet and hands, legs, arms, face, neck  were all very bad.  Applied cream and eventually returned to sleep. Gone in the morning.  Getting concerned.  Did not expect to get the rash again!
Information has been received from a registered nurse (RN) concerning a female patient with no history of chickenpox who was vaccinated with a dose of ZOSTAVAX.  The RN reported that the patient developed shingles on her face.  It was unknown if medical attention was sought.  At the time of this report, the outcome was unknown.  The RN noted that the vaccine was stored properly.  This is one of several reports from the same source.  Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 56-year-old male patient who received SHINGRIX. On 28th February 2018, the patient received SHINGRIX (intramuscular) 1 ml. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. The reporter considered the injection site pain to be almost certainly related to SHINGRIX. Additional details were provided as follows: The reporter stated he had pain in the injection site after receiving the vaccine. The vaccine was administered left upper arm. The reporter did not have the lot or expiration date. No additional details were provided. The reporter did not have complete demographics for the health care professional. The vaccine was administered at a pharmacy.
intense chills and arm pain starting ~5 hours after shot (child faded within 24 hours) arm soreness lasted ~3 days  general intense fatigue and light-headedness/ headache; decreased and went away after 48 hours
Patient states her right shoulder still has deep muscle soreness as if she's been punched in the arm
Severe hives. Spreading all over body.  Cortisol creme doesn't help Benadryl helps a little.   Lidocaine topical stops the burning.
She developed full body hives that started on her scalp and progressed down to her entire body. She went to her primary care doctor and was told to take 25mg Benadryl every 4 hours as needed and then a Claritin once daily.
This is a spontaneous report from a contactable consumer (patient). A female patient, of an unspecified age, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration on Aug 2, 2021, at 10:00, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. She stated she had every side effect listed and more. She was okay after getting the shot, but at night in bed, (Aug 2021) she experienced chills, fever, aches until midnight. Repeatedly, she tried to get up yesterday (Aug 3, 2021) and she had vertigo, dizziness, nausea and diarrhea. She took Tylenol and left her feel so weak. She experienced shortness of breath and she had chills again yesterday. All day, she wondered if the shortness of breath was related to the vaccine. Therapeutic measures were taken as a result of chills, fever, aches, vertigo, dizziness, nausea and diarrhea. At the time of this report, the outcome of shortness of breath and felt so weak: unknown; other events: recovering. The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow-up. Follow-up attempts completed. No further information expected.
Severe aching, stabbing pain and tenderness of left arm and chest muscles.  Pain and stiffness causing limited range of motion in left arm and shoulder. Pain radiating into my clavicle area . Inability to do all of my activities of daily living without limitation and severe pain. (ie. bathing, putting on clothing, normal house duties) Difficulty doing my daily online business affecting my income due to the pain and distraction from the pain. These symptoms/signs have persisted since 4/6/21.
small blister all over body; fever; headaches; This spontaneous report has been received from a consumer via Pfizer, regarding a 35-year-old female patient. The patient's concurrent conditions, medical history, and concomitant medications were not provided.  On 01-SEP-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (manufacturer unknown) as prophylaxis (dose, route of administration, anatomical location of vaccination, lot number and expiration date were not provided) and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP vaccine) (dose, route of administration, anatomical location of vaccination, indication, lot number and expiration date were not provided). However, after the vaccines, on an unspecified date in 2021, the patient presented small blister all over body (blister), fever (pyrexia), and headaches (headache). Therefore, the primary care physician (PCP) prescribed medications (meds) (unspecified) and the events (also reported as symptoms from vaccines) were resolved on an unspecified date in 2021.  The causality assessment between both suspect vaccines and blister, pyrexia, and headaches were not provided.
At 30 hrs seen for sterile, urticarial abscess, left arm, IPV and DTaP given left arm. 5.75 x 6.5 elevated non tender area upper arm at shot site. Clarinex 2 tsp every 24hrs.