chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I broke out into sever hives all over my legs. I noticed them around 5:00 pm, but I had been itchy prior to that I just did not notice the hives. Once I noticed the hives I took a shower, then contacted the pharmacy where I got the shot at, then took to Benadryl tablets. I also put some extra strength Benadryl cream on my legs as well. The hives were on both legs from the top to the bottom. Very red and blotchy in color, raised all over.  I kept an eye on it through out the night and re-applied cream. I did not go to the hospital or the doctor.
Patient's occupation: PRIVATE. complains of numbness in the right hand, inability to full grip on equipment. Also complains of very dry eye lids forming crust around the eyelids.
Local reaction, redness at site low grade temp x 1 day to use ice, BENADRYL, TYLENOL.
Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 24Feb2021 at 05:30 (at the age of 73-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included blood thinners since an unknown date an unknown if ongoing. On 24Feb2021 at 23:00, the patient experienced sore arm. Therapeutic measures were not taken as a result of the reported event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore arm was recovered on unknown date in Feb2021.   No follow-up attempts are required, information about lot/batch number cannot be obtained. No further information is expected.
TOOK VIVOTIF WITH HOT WATER; This spontaneous case report was received from a pharmacist (PVX2019-624) on 08-Mar-2019. It described a female consumer who "took Vivotif with hot water". The consumer was receiving oral Vivotif for an unknown indication.  It was reported that the consumer took the first dose of Vivotif with hot water out of the tap.  The action taken with Vivotif with respect to the event "took Vivotif with hot water" was not applicable.  The clinical outcome of the event "took Vivotif with hot water" was unknown.  Company's Comment: The causality of the event "took Vivotif with hot water" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took Vivotif with hot water" was considered as not applicable.
fluzone quadrivalent was inadvertently administered to 10 patients instead of fluzone HD, with no ae; Initial information received on 11-Nov-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2019SA316262, 2019SA316289, 2019SA316290, 2019SA316263, 2019SA316286 and 2019SA316288 (same reporter).  This case involves a 79 year old female patient who received 0.5 ml dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Lot no: UJ305AA, Expiry date: 30-Jun-2020) via intramuscular route in left deltoid on 07-Nov-2019 instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to wrong vaccine administered.  It was reported that Fluzone quadrivalent was inadvertently administered to 10 patients instead of Fluzone High dose.  At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
This is a spontaneous report from a contactable consumer or other non-HCP. A male patient, of an unspecified age, received the 2nd dose of BNT162B2 (Comirnaty, solution for injection, batch/lot# and expiration date: unknown), via an unspecified route of administration, on an unspecified date, for COVID-19 immunisation. The patient's medical history and concomitant medication not reported. Historical vaccine included the 1st dose of BNT162B2 (Comirnaty, solution for injection, batch/lot# and expiration date: unknown), single dose, for COVID-19 immunization. Patient stated he received both doses Pfizer COVID-19 vaccine. The second dose was 8 days ago. 1 or 2 days after it, he had joint pain: knees, elbow, shoulders, hands and back. He usually takes naproxen for that; but the vaccination providers said he could only take Tylenol or Aspirin (has not been helping, it just slightly lessens the pain). He takes Tylenol 3 times a day. The outcome of all events: unknown.
Pt reports that about 2 weeks after 1st dose she noticed "nerve pain" in both arms. Pain in the shot arm was more prominent. Pain was not severe, but nagging. Reports continued numbness in both hands and some in both feet. She said the pain and numbness has not worsened, but is persistent.  Reports no history of any nerve pain. No previous reactions to vaccines.
01/21/2021 @ 14:45 staff notified of client in parking lot, waiting her 15 min waiting period, stating her tongue was numb, O2 at 8Lpm/NC started. At 14:57 numbness sensation had resolved. PCP notified, ct referred to ER. Spouse drove ct to ER, assessed by Doctor, only BP monitored, tongue sensation gone, MD told ct he was unsure if reaction was from the vaccine or not, in the ER for 1.5hrs then d/c home. Ct agreed to f/u with PCP to be evaluated to determine if ct should receive dose #2. If t second dose recommended ct will be scheduled to receive at the hospital.
Non stop vomiting, bloody nose, coughing, nausea, fever and chillds
Burning and tingling in arm, chest, leg on left side (injection side). Redness in face, chest. Swelling , tightness in nasal passages, upper palette, throat.  Tightness when swallowing.   Pharmacist gave me Claritin.
This spontaneous report was received from certified medical assistant concerning a patient of unknown age and gender. On 15-SEP-2007, the patient was vaccinated with the first dose of Hepatitis B vaccine (Recombinant) (manufacturer unknown) (lot number, expiry date, dose and route unspecified). On 11-OCT-2007, the patient was vaccinated with the second dose of Hepatitis B vaccine (Recombinant) (manufacturer unknown) (lot number, expiry date, dose and route unspecified) which was too early. On 10-Apr-2008, the patient was vaccinated with the third dose of Hepatitis B vaccine (Recombinant) (manufacturer unknown) (lot number, expiry date were reported as 655149/0006U and 09-MAY-2009 respectively, dose and route unspecified) which was too late. No concomitant therapy was reported. On an unspecified date, Hepatitis antibody testing was performed which showed that the patient had low immunity to hepatitis B. The outcome of the event was unknown. The relatedness for the event was unknown for Hepatitis B vaccine (Recombinant) (manufacturer unknown). Additional information has been requested.
Information has been received from a pharmacist  and refers to an 83 year old female patient. The patient had no drug reactions/allergies. Information of concomitant therapy and pertinent medical history was unknown. On 02-OCT-2018 the patient was vaccinated with one dose of PNEUMOVAX 23 (lot # R009162, expiration date: 20-JAN-2020, route:  intramuscular, strength and frequency were unknown) for prophylaxis. Then later that same day, she developed a red, swollen, painful area at the site of vaccine injection. As a result, she started ibuprofen (MOTRIN) therapy for the pain. On 03-OCT-2018, the redness had spread down her arm, so she went to see an unspecified physician who diagnosed her with a skin infection. The patient started treatment on cephalexin (manufacturer unspecified) therapy on the same day. It was unknown if lab diagnostics or studies were performed for the event. The patient was recovering from the skin infection, pain, swelling, and redness. The causality assessment was not provided by the reporter. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1810USA004732:
Frequent episodes of tinnitus alternating ears beginning within two days of vaccine lasting almost two weeks No tinnitus before vaccination
Information has been received from a health professional concerning a patient (13 out of 40) who was vaccinated with Pneumovax 23 (lot number 651406/0620F).  It is unknown if the patient was vaccinated with the influenza virus vaccine (unspecified) on the same day.  Subsequently the patient experienced fever, pain at injection site, redness at injection site, swelling at injection site and red streaks on injection arm.  Subsequently, the patient recovered from fever, pain at injection site, redness at injection site, swelling at injection site and red streaks on injection arm.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot complies with the standards of the agency and was released.  Additional information has been requested.
(L) arm - red and warm to the touch. Levofloxacin 500 mg 1 QD x 7 days. Dx: Cellulitis.
patient states that the day after the vaccine he developed chest pains feeling like his heart was going to explode. He went to the nearby hospital er and they advised him to seek treatment from a cardiologist
Report received from a Registered Nurse (RN) on 20-OCT-2008.  An adult female patient (age and patient initials unknown) received a dose of AFLURIA (0.5 ml) from the pre-filled syringe at 3:00pm.  At 7:30pm, she experienced itching.  She felt itching on feet and it progressed all over her body.  There was some redness after she scratched.  One source other than the RN said the patient was showing hives.  Patient had no respiratory symptoms.  She went to the emergency room (ER) around 8:00pm and received BENADRYL as well as a prescription for PREDNISONE.  She left the ER at 9:00pm.  The next day patient stated that she was doing ok.  It is not known if the patient is allergic to any food or drugs.  Additional information has been requested.  No serious criteria mentioned.  Causality: Possible.  Follow-up information was received on 21-Oct-2008 from the RN.  The RN provided a few additional details.  The patient is an employee at the nursing home.  On 15-Oct-2008, AFLURIA was administered to all employees and residents at the nursing home.  The patient, is a 39 year-old female employee at the nursing home.  RN reiterated that subject experienced itching after vaccination.  She felt itching on feet and it progressed all over her body.  Patient is fine now.  Per the RN, approximately 240 doses were given and this was the only reaction.  RN "did not consider this as an adverse reaction but rather a known side-effect from the vaccination".  No additional information is expected.  No change in assessment.  Information derived from this AE report does not change the current safety profile of the product.
Received vaccine just after 12:30 PM on April 10th.  Just prior to midnight on April 10th started getting some minor body aches.  After midnight a low grade fever started along with chills.  Was shivering quite a lot from about 1:00 AM to 4:30 AM on April 11th.  Had a headache as well starting at midnight along with fever, chills, aches, and shivering.  Body aches and low fever continued through April 11th and were gone by April 12th.  Noticed lymph nodes swelling quite a bit under my left arm (arm that had the shot) through April 15th.  Swelling went away and have not had any side effects since.
This spontaneous report as received from a program manager (also reported as Health Care worker) refers to multiple patients of unknown demographics. The patients medical history and historical conditions are not reported. It was reported that on an unknown date the patients were vaccinated with ROTATEQ (unknown strength, dose and frequency) that was stored improperly. No product quality complaint was reported. The outcome of the event is unknown. Additional information has been requested.
Pfizer 4/19/21, 5/10/21. Positive on 9/12/22
Patient was admitted to observation level of care on 8-9 with weakness. Patient noted to have had a gradual fall on date of admission. Patient does have mild dementia. There is a HCPOA on file but is not currently activated. Patient did test positive for covid on 8-8.
Slightly sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 21Mar2021 (Batch/Lot number: unknown) at the age of 77 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 22Mar2021, outcome "recovered" (23Mar2021), described as "Slightly sore arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: The patient had no known allergies. The patient had not received any other vaccines within 4 weeks and had not been diagnosed with COVID-19 prior vaccination. Since the vaccination the patient had not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Received shingles vaccine - 4/23/08.  Rash around injection site came 4/25/08 and lasted 2 days and cleared.
S/S  after recieving second dose ; severe HA,  fever,  painful Erection for 3.5 hrs, swollen lips, muscular pain . Bilateral L/E pain.   Treatment tylenol 500 prn.
c/o ?chest pain w/swelling of lip & lt eye w/hives 3hr p/vax;c/o joint pain 2 days p/incident;c/o earlier in day a/shot abd pain but afeb & feeling well when shot was given;DPH given in ER;
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 4:08 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 4:08 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 70.16.  Concomitant products were not reported.  On 11-Jan-2021, At excursion time 09:00 AM, temperature was 34, total doses given for the day was 98 and at 02:00 PM, temperature was 35, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 08-Jan-2021, vial was moved to clinic on 11-Jan-2021. 9 vials were sent to clinic. Vaccine BUD date was 07-Feb-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
This spontaneous report as received from a physician refers to a 32 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 01-OCT-2015, the patient was vaccinated with her first dose of VARIVAX 1350 U (lot # L017997, expiration date 19-MAY-2015) dose 0.5 ml, subcutaneously in the left arm. On 02-OCT-2015, the patient developed a low-grade fever, body aches, and lethargy. On 02-OCT-2015, the patient also developed redness, swelling, warmth, and pain at the injection site on her left arm and two small vesicles on her left shoulder. The patient was evaluated at an unspecified emergency room on 02-OCT-2015 and was prescribed TYLENOL and ice compresses to the injection site. The patient was evaluated in the office on 05-OCT-2015. At that time, the vesicles were crusted and the other symptoms were resolving. The relationship between the events and VARIVAX and action taken were not reported. Additional information has been requested.
pt devel a sl fever & was given APAP 2hr later;temp was 105.1 & given sponge bath & more APAP;t105.8 then had a sz;before ambulance could arrive;also devel a rash, diarrhea, swollen glands & throat/ear infect;
generalized body soreness.; severe migraine; severe weakness; left arm (same arm she received vaccine) broke out in a red itchy rash; red itchy rash; feeling hot; dry heaving; severe painful coughing; severe painful coughing lasted about an hour along with post nasal drip appearing; within 2 hours my skin became blotchy and itchy; within 2 hours my skin became blotchy and itchy; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0142 and expiry date: unknown), via an unspecified route of administration on the left arm on 05Jan2021 17:30 at a single dose for COVID-19 immunization. Medical history included autoimmune progesterone dermatitis, Reynaud's syndrome, skin mottling, gastrooesophageal reflux disease (GERD), migraines, post-traumatic stress disorder (PTSD), sulfa allergy, and depression. Patient was not pregnant. The patient's concomitant medications included PEPCID.  The patient previously took progesterone, miconazole and hydroxychloroquine sulfate (PLAQUENIL) and experienced allergy.The patient experienced within 2 hours her skin became blotchy and itchy on 05Jan2021 18:45. She took a shower and symptoms resolved. Next morning on 06Jan2021, patient's left arm (same arm she received vaccine) broke out in a red itchy rash. She took Prednisone 40mg around 10am and rash resolved. Around 3-4pm the rash reappeared along with feeling hot on the same day. She ran outside and began dry heaving and coughing. The severe painful coughing lasted about an hour along with post nasal drip appearing on 06Jan2021. During that hour patient took Zofran,12 puffs of Albuterol total, and Benzedrex nasal spray. She was already on Pepcid 20mg- 2 tablets BID for GERD prior to reaction; cough improved. On 07Jan2021, around 2-3am morning woke up with a severe migraine and cough returned along with severe weakness. Patient went to the clinic she worked and received steroid shots to help along with Maxalt and more Albuterol. By Sunday, 10Jan2021, she was almost back to base like, generalized body soreness. Monday (11Jan2021) back to base line for the most part. The patient underwent lab tests and procedures which included nasal swab: negative on 08Jan2021. Outcome of the events was recovered with sequel. The reporter considered the events as non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and had been tested since the vaccination.
pt reported that had diarrhea & vomited tiwce the morning p/recv flu shot;pt recv yellow fever vax before the flu shot;
first dose administered after temperature excursion; vaccines experienced a temperature excursion for a duration of 1 hour and 24 minutes; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines experienced a temperature excursion for a duration of 1 hour and 24 minutes) and EXPIRED PRODUCT ADMINISTERED (first dose administered after temperature excursion) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Sep-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines experienced a temperature excursion for a duration of 1 hour and 24 minutes). On 20-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (first dose administered after temperature excursion). On 18-Sep-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines experienced a temperature excursion for a duration of 1 hour and 24 minutes) had resolved. On 20-Sep-2021, EXPIRED PRODUCT ADMINISTERED (first dose administered after temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported. On 18-Sep-2021, the fridge and freezer storing vaccines experienced a temperature excursion  for a duration of 1 hour and 24 minutes. When excursion occurred, 10 vials(1 carton) of Moderna COVID-19 vaccine was reported to be stored in the fridge. On 17-Sep-2021, the vials were moved from freezer to fridge, a day prior to the excursion. On 20-Sep-2021, two doses out of the vial of the affected Moderna COVID-19 vaccine was administered to two patients and the remainder of the vial was discarded after use.   This case was linked to MOD-2021-329344, MOD-2021-329370 (Patient Link).