chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 83-year-old female patient who received SHINGRIX (batch number 49R72, expiry date 13th March 2021) for prophylaxis. On 13th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In November 2018, less than a month after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site discoloration and injection site erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site discoloration and injection site erythema were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site discoloration and injection site erythema to be related to SHINGRIX. Additional information received as follows: The patient experienced swelling at injection site of 3 by 4 inches in area. The reporter also describes area was white in color at injection site and then red around.
Blurred vision after 20 minutes, lasted 10 minutes and resolved.  Coughing and slightly swollen throat after 30 minutes, lasted 15 minutes and resolved. Bloody spit after coughing but resolved after an hour. Fatigue after 2 hours, extreme headache and nausea began after 4 hours. All were reduced after 12 hours, but none have resolved yet 48 hours later.
Initial information received on 13-Mar-2019 regarding an unsolicited valid non-serious case received from other health care professional. This case involves an unknown demographic patient who was vaccinated with a dose of vaccine IPOL (lot number, Exp. Date, dose, route and site of administration not reported) which was stored incorrectly on an unknown date. The patient's medical history and concomitant medications were not reported. It was an actual medication error case due to incorrect product storage. It was reported that a dose of IPOL was involved in the previously reported excursion. Caller stated she was unsure if the IPOL was opened before the patient was given a dose. It was unknown whether 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 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. List of documents held by sender: none.
Temperature of 102 degrees.  Site very red and swollen.  Had had a reaction previously but 3 immunizations had been given at reaction site and we were unable to know which had caused the reaction.  Mother called and talked to private physician who felt this was a reaction to the Pertussis but did not see the child.  Child is currently doing ok with no lasting symptoms.
No additional AEs were reported; The nurse reported that 33 patients received improperly stored vaccines; This spontaneous report was received from a Licensed Practical Nurse and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 14-MAR-2022, the patient was vaccinated with improperly stored Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (dosage regimen was not reported), lot # U026217 and expiration date 02-NOV-2023, and with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ)  (dosage regimen was not reported), lot # 1741817 and expiration date 30-JUL-2022, administered as prophylaxis.   The improperly stored dose of the suspect vaccine experienced a temperature excursion of 34.3 degree fahrenheit (F) for 55 minutes; no previous temperature excursions were reported.  The call was made due to a digital data logger. No adverse symptoms were reported.; Sender's Comments:  US-009507513-2204USA001791: US-009507513-2204USA001821: US-009507513-2204USA001816:
Pain in arm where vaccine administered, unable to fully lift arm over head, tingling, numbness radiating down arm.
Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild
This case was reported by a physician and described the occurrence of Henoch-Schonlein purpura in a 14-year-old female subject who was vaccinated with Boostrix for prophylaxis. Concurrent vaccination included Menactra given on 06 March 2007. On 6 March 2007 the subject received 1st dose of Boostrix at 0.5ml, intramuscularly, in the right arm. On 14 March 2007, 8 days after vaccination with Boostrix, the subject experienced Henoch-Schonlein purpura all over her body. At the time of reporting the event was improved. The physician considered the event was probably related to vaccination with Boostrix.
This case was considered medically important. Information regarding PREVNAR was received from a healthcare professional regarding a 6-month-old male patient who experienced white spot and muscle atrophy (described as pitting). At 6 months of age, the patient received the third dose on 26-Jan-2010. The patient also received the second dose of PENTACEL (Aventis-Pasteur), a dose of Hepatitis B Vaccine (manufacturer unknown) and the third dose of ROTATEQ (Merck & Co Inc) on 26-Jan-2010. Patient received the third dose of PREVNAR therapy on 26-Jan-2010, at the age of 6 months. In February of 2010, a white spot appeared on his left thigh where the vaccine was given and his muscle started to atrophy described as pitting. On 25-Aug-2010 at the age of 13 months, the patient visited the clinic again and the muscle atrophy and pitting was 3 plus deep and quarter-sized. Treatment was not provided. At time of report, patient had not recovered.
administered after temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 3-year-old male patient who received HAV (Havrix) (batch number 2K57N, expiry date 11th December 2022) for prophylaxis.   Co-suspect products included DTPa (Infanrix) (batch number 7EC55, expiry date 29th April 2023) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th March 2022, the patient received the 2nd dose of Havrix, Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix, Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-Jun-2022 Reporter's comments: Medical assistant reported that the patient was administered with the Havrix in left arm and Infanrix in right arm after a temperature excursion. The consent to follow up was given. Additional Supportive Information: The patient was administered with the Havrix and Infanrix after a temperature excursion, which led to incorrect storage of drug. This was 1 of the 11 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022093637:Same reporter US-GLAXOSMITHKLINE-US2022093643:Same reporter. US-GLAXOSMITHKLINE-US2022093600:Same reporter. US-GLAXOSMITHKLINE-US2022093597:Same reporter. US-GLAXOSMITHKLINE-US2022093602:Same reporter. US-GLAXOSMITHKLINE-US2022093648:Same reporter. US-GLAXOSMITHKLINE-US2022093646:Same patient - FU1 US-GLAXOSMITHKLINE-US2022093640:Same reporter. US-GLAXOSMITHKLINE-US2022093642:Same reporter. US-GLAXOSMITHKLINE-US2022093644:Same reporter. US-GLAXOSMITHKLINE-US2022093647:Same reporter.
Gillian-Barre` syndrome type.  Nearly comatose; loss of all muscle control in entire body for nearly 48 hours.  Could not walk or move muscles.  No control over urination or defecation.  Still unable to walk without using a cane.  Imbalance.  Weakness, muscle pain and fatigue.
Pt in for college IZ and post vax, she fell into mom's arms and laid on the floor. The RN was at pt's side. BP 120/68. EMS was called and when they arrived, pt stated she felt better. EMS sent away. Pt states complaints of tingling over body, headache, and "feeling sick". EMS recalled by PMD. BP 80/48, lying down and 90/50 sitting up per RN. EMS arrived, pt transported to ER. Doctor feels pt had a panic attack and not a reaction from shots per RN.
Localized pain at injection site; Severe joint pain; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 04May2021 at 14:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Medical history was not reported. Concomitant medications taken within two weeks of vaccination included lisdexamfetamine mesilate (VYVANSE) for unknown indication from unknown date and unknown if ongoing. The patient previously took neomycin sulfate; polymyxin b sulfate; gramicidin (NEOSPORIN) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the right arm on 13Apr2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04May2021 at 21:00, the patient experienced localized pain at injection site and severe joint pain. Therapeutic measures were taken as a result of the events and included treatment with paracetamol (TYLENOL) and ibuprofen (MANUFACTURER UNKNOWN). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events localized pain at injection site and severe joint pain was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.
Allergic reaction.  Coughing, facial swelling and hives 15 minutes after leaving the office.  Epi pen administered by mother en route to medical center.  Treated in ED and discharged home same day.  5/20/08 Reviewed ER medical records of 4/7/2008. FINAL DX: allergic reaction Records reveal patient experienced itching, SOB, throat tightness, rhinorrhea, chest tightness & hives approx 2 hours s/p vaccination.  Developed redness & swelling at varicella injection site.  Used epi-pen & antihistamine at home.  Called EMS who found patient SOB w/eye swelling, face red.  Tx w/steroids.  Improved & d/c to home on continued meds.
Patient reports fever, diminished activity, and fatigue; Had two days fever after her second shot as well as weakness and fatigue - rough 2-3 days but now feeling somewhat better. Feels like she has weakness in her legs - has been very fatigued since the second shot. She reports itchiness, redness, and rash; RIGHT arm at the site of the second COVID vaccine - initially redness, edema and pain - now just redness (like sunburn).  had balance issues after the shot - has improved.
Mom states pt exp t104 oral, fussy 4 days p/inject; Given APAP which brought fever down; Also exp loose stools noted 5-6 days p/immun given;
Severe rash started in bicep of left arm and spread all the way down arm and then started in bicep area of right arm  and continued all the way down right arm  --still vivid in both arms after six weeks ,has never gone away
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 24-AUG-2020, the patient was vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally as prophylaxis (lot # 1660991 with expiration date 27-APR-2021) (strength and frequency were not reported) and with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 ml as prophylaxis (lot # S036821 with expiration date 21-APR-2022) (strength, frequency, route of administration and anatomical location were not reported).  The improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter. ; Sender's Comments:  US-009507513-2009USA006106:
Fever 100.2 for approx 18 hours, nausea, headache
sleep pattern is kind of messed up; feeling fatigued; hasn't been able to sleep as normal; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (feeling fatigued), INSOMNIA (hasn't been able to sleep as normal) and SLEEP DISORDER (sleep pattern is kind of messed up) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included DEXTROAMPHETAMINE HYDROCHLORIDE, LEVOTHYROXINE, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), AMLODIPINE, LAMOTRIGINE, LISINOPRIL, CETIRIZINE, ATORVASTATIN, SILDENAFIL, SUVOREXANT, MULTIVITAMINS & MINERALS PLUS LUTEIN and FISH OIL.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced FATIGUE (feeling fatigued) and INSOMNIA (hasn't been able to sleep as normal). On an unknown date, the patient experienced SLEEP DISORDER (sleep pattern is kind of messed up). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, FATIGUE (feeling fatigued), INSOMNIA (hasn't been able to sleep as normal) and SLEEP DISORDER (sleep pattern is kind of messed up) outcome was unknown. Not Provided.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included DEXTROAMPHETAMINE HYDROCHLORIDE, LEVOTHYROXINE, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), AMLODIPINE, LAMOTRIGINE, LISINOPRIL, CETIRIZINE, ATORVASTATIN, SILDENAFIL, SUVOREXANT, MULTIVITAMINS & MINERALS PLUS LUTEIN and FISH OIL. The patient was treated with IBUPROFEN.
Patient is a 69 y.o. male presents with cough and progressive hypoxemia at home.  Minimal cough.  Loss of smell and taste that occurred 4 days ago.  5 days ago he began with symptoms.  He tested positive for Covid the next day.  His wife is also ill about the same time and is tested positive for Covid.  The daughter was ill 1 week prior with Covid and is virtually returned to normal at this point in time.  Patient denies a prior history of hypoxemia.  He has unexplained splenomegaly.  He has a history of obstructive sleep apnea on CPAP.  Prior history of stroke felt to be embolic.  He also has a history of DVT and factor V Leiden mutation.  He has been on anticoagulation following that event.  He and his family members have all been previously immunized.  He did go to a 3 game baseball series in the few days before his illness began.  Also attended a large outdoor event.  Quite crowded.  Admitted to telemetry unit 9/27/21
Information has been received from a Licensed Practical Nurse via sales representative regarding an unspecified number of patients of unknown age. The patients medical history, drug reactions or allergies were not provided. On an unknown date, the patients were vaccinated with a dose of ZOSTAVAX (dose, route and lot number were not provided). On an unknown date, the patients developed rash after receiving ZOSTAVAX. The outcome of rash was unknown. Additional information is not expected.
SWELLING AT INJECTION SITE. SWELLING HAS COME DOWN AS OF 10/27/12.
Pt recv vax on 10/28/98; on 10/29/98 pt exp swollen facial cheeks w/ erythema, headache & nausea; LA ecchymotic at vax site.
slightly sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (slightly sick) in a 102-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced ILLNESS (slightly sick). At the time of the report, ILLNESS (slightly sick) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication information was not provided. Treatment information was not provided.   This case was linked to MOD-2021-417671, MOD-2021-417678 (Patient Link).
Client complained of stomach pain and headache; mother gave Advil for headache and Pepto Bismol for upset stomach.
Fever, body aches (muscle and joint), headache, chills, sweats, tiredness, urge to cry (7 am - 2 am)
had loss of smell; had loss of taste; she had the flu; she was sick; fever 101 and 103; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (she had the flu), ILLNESS (she was sick), PYREXIA (fever 101 and 103), ANOSMIA (had loss of smell) and AGEUSIA (had loss of taste) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced INFLUENZA (she had the flu), ILLNESS (she was sick) and PYREXIA (fever 101 and 103). On 07-Mar-2021, the patient experienced ANOSMIA (had loss of smell) and AGEUSIA (had loss of taste). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 400 mg 2 doses. On 07-Mar-2021, INFLUENZA (she had the flu), ILLNESS (she was sick) and PYREXIA (fever 101 and 103) had resolved. At the time of the report, ANOSMIA (had loss of smell) and AGEUSIA (had loss of taste) had resolved.            No concomitant medications provided.
Developed papular rash diffusely on face.  Associated with mild pruritus. No redness, warmth, tenderness. Rashes been present for 6 days and is improving.
Erythema, warmth, swelling, pain. Measured 15cm x 17cm pink and swelling on 1/23/07 gives history of having pertussis disease 2 yrs ago.  Follow-up states - MMR II vaccine lot number actually 0862F. Record updated.
sore throat; Tenderness of the Right Arm; This is a spontaneous report from a contactable consumer (patient herself). A 76-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Batch/lot number: EH9899), via an unspecified route of administration on the right arm, at age 76 years first dose on 22Jan2021 at single dose for COVID-19 vaccination. Medical history was none. There were no concomitant medications. Patient had the vaccine first dose on Friday (22Jan2021), she had tenderness in the arm at the site but nothing major. Then this morning (27Jan2021) she had a really bad sore throat, it's really sore. She asks if this is a side effect. She asks can she take aspirin or Tylenol. Reporter Type: She has worked in a doctors office in the past but it was just doing medical records. She confirms that on 22Jan2021 was her first dose of the covid vaccine, the tenderness of the arm was on the same day, it happens anytime she gets a shot, the Sore Throat started this morning. Primary care: Declined, she has only been going through the vaccine program. The tenderness of the right arm, is barely there, its like nothing there, its just a little. For the Sore Throat , she drank from tea and had a lozenge and so its not as but is still there but not terrible. Patient stated that she just want to know if she can take aspirin or Tylenol Covid Vaccine Card: The Expiry is not written on the card. Date of second dose: 12Feb2021 Concomitant Medications; No She was just sleeping and woke up with it.  The outcome of the event sore throat was not recovered, while for the other event, it was recovering.
One day after first shot, joint pain started. Fingers, knees, heels, and toes. Feel pain when grabbing, moving, typing with fingers, sometimes feel the pulsing pain even when not moving or going anything. Knees hurt, can't stand for long (even like half hour), heels and toes hurt when walking/going up and down the stairs. Never had joint pain before in my life. Been almost 2 months and still feel the pain. Within an hour of second shot, severe headache, on both sides of temple and back of head. Been 3 days and headache hadn't gone better. Day and night.
Patient had his 12 month check up 10/24/2012 and was given the Hepatitis A vaccination along with other vaccinations....Yesterday, the nurse gave him another dose of Hepatitis A and was suppose to give him the Flu Shot instead....The nurse called me at 5 pm last night and left a message on my cell phone to call her back the next day...Today, I called her and she said that she was very sorry to give him another dose and that he will be fine..Nothing will be wrong with him...She should of looked at his chart...They should be checking to make sure that this does not happen....She could of given him something else...I am looking out for the welfare of my child and other children who go to that clinic...This should of never of happened and it was only 4 weeks of the second dose....My husband and I are going to get his FLU shot at 3 PM today  11/27/2012 and hopefully talking to the DR...in what he has to say about this....
Near death experience; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer reported that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reporter is (Name) who said he just got off a phone call with a person who was no longer on the other line and disconnected, they were no longer there. He said he wanted to report an adverse event mentioned on the call for which reporter provided no name or no phone number but said they had a friend who received a COVID-19 vaccine and after that had a near death experience, that afterwards the vaccine nearly killed them. Agent reported the COVID-19 vaccine was not clarified as either Pfizer or Moderna. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.