chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Patient was administer vaccine 4 days after BUD date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administer vaccine 4 days after BUD date) and NO ADVERSE EVENT (No adverse event) in a 4-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 31-Jan-2023,  after starting , the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administer vaccine 4 days after BUD date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administer vaccine 4 days after BUD date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient was administer vaccine 4 days after BUD date).    Concomitant products were not reported.  It was reported that patient was administered with vaccine four days after the BUD date which was 27-Jan-2023. Patient previous vaccination details was first dose on 30-Aug-2022, Lot number AS1412B. Second dose on 27-Sep-2022, Lot number AR9236B.  Treatment medications were not reported.
My arm swelled all up; I still have a big black and blue mark all like a size of an orange on my arm; I was so tired, I went to bed at 6 o clock at night and didn't wake up to 8:30 in the next morning; I was so cold; I got the chills, I was so cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "My arm swelled all up"; SKIN DISCOLOURATION (non-serious), outcome "unknown", described as "I still have a big black and blue mark all like a size of an orange on my arm"; FATIGUE (non-serious), outcome "unknown", described as "I was so tired, I went to bed at 6 o clock at night and didn't wake up to 8:30 in the next morning"; FEELING COLD (non-serious), outcome "unknown", described as "I was so cold"; CHILLS (non-serious), outcome "unknown", described as "I got the chills, I was so cold".  Additional information: I went to bed at 6 o clock at night and didn't wake up to 8:30 in the next morning and I am concerned if I should have the second shot or not."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient complained of nausea/vomitting, redness,tenderness, swelling at the injection site, fatique on day 8th after first dose of her covid vaccine. Recommended patient to continue hydrating, may take otc antiemetic. On day 12th, patient stated that her symptoms subsided, she feels much better now.
Information has been received from a physician concerning an unknown number of patients who were vaccinated with a dose of ZOSTAVAX. it was reported that the patients were supposed to receive a dose of VARIVAX. It was reported that the office had run out of VARIVAX and the nurse had been giving 1 year old children ZOSTAVAX instead. It was reported that ZOSTAVAX had been administered to children over approximately during the month of May 2007 and June 2007. The physician reported that she was not aware of any adverse events or Varicella in the patients. The physician stated that the office was in process of contacting the parent/gardian of every child who received ZOSTAVAX. The office had planned to develop a standard "questionnaire" that would be used to obtain consistent information. The physician also stated that she did not know exactly how many children were involved and stated that it could be a "large number". Attempts are being made to obtain additional identifying information to distinguish the individual patients mentions in this report. Additional information will be provided if available.
10 X 9 welt with swelling and redness within 4-6 hours after immunization
Hand locks up and left side of face freezes called dt he said not to get in future - patient has had flu vaccine previous to this .
severe fatigue; Chills; headache; This is a spontaneous report from a non-contactable consumer, the patient. A 65-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER 8727) via an unspecified route of administration in the arm left on 09Apr2021 at 12:00 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not have allergies to medications, food, or other products. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN 6307) via an unspecified route of administration in the left arm on 18Mar2021 at 15:30 (at the age of 65-years-old) 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. On 10Apr2021 at 12:00 almost exactly 24 hours after receiving the injection, the patient experienced severe fatigue, chills, and headache, but no fever. She took acetaminophen and went to bed. Symptoms continued for at least 12 hours, and were gone by the next morning. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event severe fatigue, chills and headache were recovered on 11Apr2021.    No follow-up attempts are possible. No further information is expected.
a patient received an expired dose of PROQUAD; This spontaneous report was received from a nurse referring to a patient of unknown gender and age. Information regarding the patient's pertinent medical history, current condition, drug reactions/allergies and concomitant medication were not provided.  On 26-JAN-2021, the patient was vaccinated with expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live with albumin status rHA (recombinant Human albumin) (PROQUAD) 1 injection (strength, route of administration and anatomical site of vaccination were not reported, lot # S021620, expiration date reported and validated as 09-JAN-2021) for prophylaxis (expired product administered). No further questions, no further adverse events (AE).
My shoulder has never recovered full range of motion since the day of vaccination. I am unable to lift hand to unlatch bra strap or reach an itch on my back like I could before the shot. When I do,  my shoulder hurts and I am unable to complete the task.
This case was reported by a physician (the subject's father) and described the occurrence of abdominal pain in a 2-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent vaccination included Haemophilius influenza type b vaccine; manufacturer unspecified; unknown given on 28 April 2010. On 28 April 2010 the subject received unspecified dose of ENGERIX B (.5 ml, unknown route and site). On 28 April 2010, less than one day after vaccination with ENGERIX B, the subject experienced abdominal pain and cramps, crying, "squealing" and "squirming". The abdominal pain and cramps lasted for 45 minutes. At the time of reporting the outcome of the events was unspecified.
Side effects after my booster (3rd shot): Very sore arm the day of the shot, which lasted for about a week. On day three, I felt strong heart palpitations that lasted for a few minutes, a couple times throughout the day. These daily heart palpitations lasted for two weeks. I developed shingles the day after my shot. I have a group of blisters on the right-side of my neck. It is now Dec 20th, and they have not gone away. Now I have blisters showing up on my face (cheeks).
Fever; Itching; Rash; Swollen lymph nodes; Nausea; Injection site pain; Tiredness; Headache; Chills; Dizziness; Blurred vision; This is a spontaneous report from a contactable healthcare professional, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: FA7484) via intramuscular route of administration in the left arm on 28Jul2021 at 12:45 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included hepatitis c and allergies to opioids, iodine, shellfish and environmental. 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 glecaprevir;pibrentasvir (MAVYRET) for unknown indication from an unknown date and unknown if ongoing. Patient previously took codeine (MANUFACTURER UNKNOWN) and experienced drug allergy. On 28Jul2021 at 13:30, the patient experienced fever, itching, rash, swollen lymph nodes, nausea, injection site pain, tiredness, headache, chills, dizziness and blurred vision. Therapeutic measures were taken for the reported events and included treatment with ibuprofen (MANUFACTURER UNKNOWN). 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 events fever, itching, rash, swollen lymph nodes, nausea, injection site pain, tiredness, headache, chills, dizziness and blurred vision was recovering at the time of this report.
Left sided pleuritic chest pain developed about 24 hours after vaccination and continued to get worse for 2 days after which it is now slowly resolving. Used ibuprofen and tylenol PRN to help with pain symptoms.
Returning from a tour I noticed a flehm filled but none productive cough no aches nausea vomiting or diarrhea, The cough was very deep and my ribs hurt and sleep was difficult, no fever just aches and pains a sore throat with post nasal drip with hoarseness in my voice with my ears stopped up.
Chills, fever (101), achy,  fatigue, severe headache, severe reactions at site of vaccination  - mid-day then following day 4/28 continuing into next day 4/29 Fluid retention, fatigue and  severe reactions at site of vaccination 4/30
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, immediately after receiving SHINGRIX, the patient experienced pain in arm, pruritus and swelling arm. On an unknown date, the outcome of the pain in arm, pruritus and swelling arm were unknown. It was unknown if the reporter considered the pain in arm, pruritus and swelling arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX the unknown arm. The healthcare professional (HCP) stated that the patient reported pain and swelling in her arm, as well as itching around her hairline and behind her knees, all beginning shortly after administration of a dose of SHINGRIX. The HCP did not provide further details.
Patient previously received two doses of Pfizer COVID-19 vaccine Patient administered Moderna (Spikevax), 6-11 years blue/purple top at 8/10/22 office visit. Booster not approved for this age range. Patient should not have received Moderna dose.    No known adverse outcome/symptoms. Physician discussed with patient's parents.
Lot expired on April 2022 and vial was initially stored in the refrigerator on 02-Jun-2022 then administered; Expired Moderna doses given; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna doses given) and PRODUCT STORAGE ERROR (Lot expired on April 2022 and vial was initially stored in the refrigerator on 02-Jun-2022 then administered) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna doses given). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Lot expired on April 2022 and vial was initially stored in the refrigerator on 02-Jun-2022 then administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Moderna doses given) and PRODUCT STORAGE ERROR (Lot expired on April 2022 and vial was initially stored in the refrigerator on 02-Jun-2022 then administered) outcome was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications was not provided by the reporter. It was reported that HCP was unclear/unsure which doses these were only that they were boosters. On 02-Jun-2022, Vial was initially stored in the refrigerator. It was reported that vial did not undergo any temperature excursions.   Treatment information was not provided.
Swelling of lips, tongue, throat. Next day inability to swallow. Put on prednisone and addition antihistamines for two weeks, lip swelling has returned two weeks past last prednisone.
c/o lightheadedness, sob for short period. resolved. stated, "feeling weird, maybe I'm anxious." Vitals stable, Given Juice PO. 145/89, 74, 20, 100% O2sat. D/C'd after 30 minutes in stable condition 117/67, 65, 20, 100% O2 sat..
This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a elderly female patient who received SHINGRIX (batch number M77B4, expiry date 8th February 2021) for prophylaxis. On 14th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: At the time of reporting, the patient age was 81 years old. The reporter was the pharmacy student. The patient received SHINGRIX vaccine on left arm. The reporter reported that the patient experienced flu like symptoms which lasted for total of 3 days. The reporter wanted to know the efficacy of the vaccine if the patient only received the first dose of SHINGRIX. No further details were provided.
Nausea, Diarrhea, Fever, Chills, Headaches, Body Aches, lasted about 48 hours
Patient received Zostavax and developed a wound that would not heal. He eventually went to doctor and it was diagnosed as squamous cell carcinoma.
No additional AE's/PQC's were reported; Caller reported a temperature excursion for PROQUAD / PROQUAD lot: T0304081 was administered to (14) patients since the excursion occurred on 7/22/2021; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.     On 29-JUL-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 1 dosage form, lot # T0304081, expiration date reported as 07-MAR-2022 for prophylaxis (exact dose, anatomical location and route of administration were not reported).      Digital Data logger was involved. The vaccine was stored at the temperature that was reported as 13.02 degrees of Fahrenheit (F) for 1 hour and 30 minutes. There was a previous temperature excursion reported (from 14 degrees of F to 46 degrees of F (17.95 degrees of F) for 45 minutes). No symptoms were reported by the patient since the administration.  Lot # T0304081 is an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). Lot # T0304081 does not match any Company product as confirmed by Lot Verification team.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA000999: US-009507513-2108USA000995: US-009507513-2108USA000996: US-009507513-2108USA000997: US-009507513-2108USA000998: US-009507513-2108USA000973: US-009507513-2108USA001007: US-009507513-2108USA001006: US-009507513-2108USA001005: US-009507513-2108USA001004: US-009507513-2108USA001003: US-009507513-2108USA001002: US-009507513-2108USA001000:
patient began with generalized hive-like pruritic macular red rash to chest and back and upper shoulders/arms; patient complaining of fatigues without joint pain or fever
This spontaneous report as received from a nurse refers to multiple patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported.  On an unknown date, the patients were vaccinated with improperly stored VARIVAX lot# N009768 with expiry date: 24-MAR-2019, lot# N008827 with expiry date: 16-MAR-2019 and lot# M046004 with expiry date: 18-NOV-2018 (dosing details, route and anatomical location were not reported) for prophylaxis.  The vaccines were reconstituted with properly stored diluent (details not reported). It was reported that the vaccines were exposed to a temperature range of 15 F to 46 F for a duration of 3 hours and 33 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved.
Fever up to 101 degrees; Shakes; Overall soreness; This is a spontaneous report from a contactable consumer, the patient. A 57-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 right arm on 06Apr2021 at 15:00 (at the age of 57-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history and did not receive any concomitant medications. The patient did not have any allergies to medications, food, or other products. 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 four weeks prior to the COVID vaccine. On 07Apr2021 at 03:00, the patient experienced fever up to 101 degrees, shakes and overall soreness. The patient underwent lab tests which included Body temperature on 07Apr2021 at 03:00 and the result was 101 degrees (unspecified units). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the event fever up to 101 degrees, shakes, overall soreness was recovering at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Swelling, especially in face: eyes swollen shut, throat - very difficult to swallow, Itching all over body, especially in feet and hands. Vommiting and diarrhea.
Swelling, redness began 24 hrs after vaccine and more marked 48 hrs with 13x15 cm.  Tender with slight itching moderate pain.  Although not clear this was bacterial cellulitis, is rxed on 3/20/08 with cephalexin.
Right side of tongue felt numb, loss of taste on that side of mouth. On 10/10/14, the right side of my face felt very weak. My right eye lid, right side of mouth/lip, and cheek were all drooping and not moving well.  Went to doctor on 10/13/14, diagosed with Bell's palsy. I started a 60mg prednisone taper dose and Acyclovir treatment for next 2 weeks.
Information has been received from a consumer (patient's mother) concerning a male patient of unknown age, who on unknown dates, was vaccinated with three doses of MMR II at 2, 6 and 17 months of age (doses, routes and lot #s not reported). It was reported that, on unspecified date, the patient developed subsequent various reactions. After the last dose of MMR II, the patient could no longer communicate. At the time of the report, the patient's outcome was unknown. Relatedness for the events was not reported for MMR II. Additional information has been requested.
My shoulder got really hot and sore. I got a fever. I was nauseous and I would change out warm and cold compresses to help. I slept a lot. It felt like I had the flu. The heat at the injection site would come back and forth for a couple of weeks.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 11Feb2021 as dose 2, single (Batch/Lot number: unknown), in right arm, on 01Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 10Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Lupus" (unspecified if ongoing), notes: Lupus; "asthma" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLORIC ACID, start date: 17Jan2014; GABAPENTIN, start date: 12Mar2022; MELOXICAM, start date: 20May2020. Past drug history included: Tetracycline, reaction(s): "Known allergies: Tetracycline". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient also received Breo Inhaler in 2 weeks with the start date of 12Mar2022. The patient received anti viral treatment with Paxlovid for COVID-19 from 26Aug2022 to 30Aug2022. Device Date 04Sep2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Vaccine administered beyond Expiration date. However, per Moderna- all vaccines met viability requirements.  Completing VAERS per system requirements.
This consumer report (initial receipt: 12-Nov-2012) concerns a female patient, who had a medical history of osteoarthritis and had unusual pain in her arm muscles, in areas that she had not had experienced pain before. On 20-Oct-2012 the patient received a flu vaccination (manufacturer, brand name and lot number were not provided). On 26-Oct-2012 the patient received her ZOSTAVAX injection once subcutaneously. On 26-Oct-2012 (7 days after receiving flu vaccine), the patient walked to the parking lot and had the sensation that she was being electrocuted. The sensation lasted for about 4 -5 minutes. As soon as she got home she called the pharmacist who gave her the ZOSTAVAX vaccination. The pharmacist told her to see her physician. Her physician drew unspecified blood samples. Two days after receiving the ZOSTAVAX (28-Oct-2012; 9 days after receiving flu vaccine), the patient had an outbreak of chickenpox. The event outcome was recovering.
p/vax pt exp tender 10cm area of redness & swelling at inj site in lt arm; tx iced, ibuprofen & benadryl