chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX, (GlaxoSmithKline).  In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown).  In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint.  The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site.  At the time of reporting the outcome of the events were unspecified.  For the other 79 linked subjects please see cases:  A0756483A - A0756557A, A0756559A - A0756562A.  The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A.  With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA).  On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA) :  AFLUCA320, AFLUA320A, and AFLUA320B.  The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA.  On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA) :  AFLUCA350 and AFLUA350B.  The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
No additional AE reported; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion. Caller stated she did not have the exact dates of administration nor the names of the patients involved. No additional information provided. No additional AE; This spontaneous report was received from a Health Care Professional and refers to a 15-month-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 13-DEC-2022, the patient was vaccinated with the third dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) intramuscular injection, in right thigh, lot #W023937, expiration date: 06-DEC-2023, administered intramuscularly for prophylaxis (strength was not provided).  The administered dose of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes . Data logger was involved.  No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA001175: US-009507513-2301USA009088: US-009507513-2301USA009024: US-009507513-2301USA009878: US-009507513-2301USA009918:
Phone call from mother stating patient had a 3-4 inch diameter red, swollen, sore upper left arm. No fever.   Symptoms improved but not completely gone.
Tested positive for covid; Received first Pfizer covid vaccine on 23Dec, tested positive for covid; This is a spontaneous report from a contactable pharmacist.  A 75-year-old patient of an unspecified gender started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 at SINGLE DOSE for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The reporter stated "75 year old patient with some comorbidities who received first Pfizer covid vaccine on 23Dec, tested positive for covid on 28Dec. Patient has been treated at home and is doing well. What is the protocol for their second dose of Pfizer covid vaccine due on 13Jan?" The outcome of the events was unknown.  Information about lot/batch number has been requested.
Suspected Vaccination failure; had it couple years ago some doesn't go away; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient got Shingles vaccine couple of years ago and thought some experienced shingles which doesn't go away. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. This case was linked with case US2021AMR179434, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR179434:Same reporter
At home: closed throat, shortness of breath, cough, fever up to 102 F, headache, tachycardia, reddened eyes, hands/fingers swollen and red. At emergency room: acute fever, generalized allergic reaction secondary.
Severe headache for 2 days, mild for 2 weeks.  Flare of lupus of skin.  Numbness of fingers of left hand, redness of injection sight noted at day #3, lasted approximately 2 weeks
bilateral pulmonary embolism; patient reports onset symptoms 12/06/2022; did not seek evaluation until 01/06/2023 when presented with shortness of breath that had onset 12/06/2022.
About 8 days after injection, injection site became sore again. I had a knot at injection site and it was red and hot. Redness spread to about 3 inches in diameter and was warm to the touch. Very mild itching at injection site. This lasted 2-3 days, then began to subside. I didn?t go to the doctor and I didn?t take any medication for it either orally or topically.
I received the 2nd vaccine around 6:00 PM on 03/17/2021.  The fatigue hit me around 8:30 PM that night.  On 3/18/2021 I woke with fatigue, body aches, and chills.  I took Advil around 3:00PM and felt better within an hour.  Around 9:00 PM, the fatigue, body aches, and chills returned.  I took more Advil and it helped.  Today, 03/19/2021 I have the same symptoms but much less severe.
Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a dose of GARDASIL.  Subsequently, the patient developed fever and experienced chills and achiness after receiving vaccination.  On approximately 24-JUN-2008, "within the last ten days" the patient was seen by emergency room physician.  The outcome was unknown.  This is one of several reports received from the same source.  Additional information has been requested.
Vaccine was stored in the freezer for 16 days instead of the recommended 14 days. The vaccine was supposed to be removed from the freezer on 5/27 by 1pm and placed in the fridge. Instead in was kept in the freezer and given to the patient instead.
Developed severe headache lasting for 3 days that has been recurrent since 2006. Causality process results are that probably no causal relationship. Note influenza vaccine on the same day was FLUMIST, but not available on dropdown.
Erythema multiforme like lesions. Macular erythematous in the extremities, abdomen and chest started 4 hrs after shot with itching.
So prior to the vaccine I did have glaucoma which was controlled by eye drops. But then at the end of April, beginning of March I started to have pain and pressure in my eyes. I saw my eye DR and he gave me more eye drops and scheduled a surgery on my eyes. My eye pressure was 39. On the 9th of March 2021 I had surgery on my eye. I had another surgery on April 13 2021 as well.
This is a spontaneous case, initially received on 07-Nov-2018 from the other health professional (nurse), concerning a 44-year-old, adult female patient. On an unspecified date, the vaccines were stored in the refrigerator and eventually a temperature drop was noted for a moment up to plus 0.3 Celsius for less than 115 minutes, which was considered as first temperature excursion. It was reported that the vaccines were moved immediately. On 26-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, batch number: 252227, expiry date: 31-May-2019, route of administration: intramuscular, anatomical location: left deltoid) which underwent temperature excursion. At the time of this report, no adverse events were reported. This case is linked to case 201805327 due to same reporter. The reporter assessed this case as non-serious. Follow-up report received from the reporter on 28-Nov-2018: Age, route of administration and anatomical location was updated. The reporter confirmed that no adverse events were reported after vaccination. The narrative was amended accordingly.
Information has been received from a health professional concerning a female who on approximately 02-APR-2008 was vaccinated with GARDASIL (lot number unspecified).  "Approximately four weeks ago", on 02-APR-2008, the patient experienced persistent pain in her arm localized to the injection site.  There was no nerve pain or pain any where else in her arm.  The patient's persistent pain in her arm localized to the injection site persisted. The patient sought unspecified medical treatment.  Additional information has been requested.
Round circular spot on injection site, feels like a knot, warm to the touch starting 8 days after receiving the vaccine
I got Covid; I got Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old [non-pregnant] adult female received COVID-19 immunisation with the first dose of intramuscular BNT162B2 (solution for injection; Lot EL3247 expiry information not provided) as a single dose in the right arm on 20Jan2021 at 15:30 (at 50-years-old); the second dose of intramuscular BNT162B2 (solution for injection; Lot EL3247 expiry information not provided) as a single dose in the right arm on 08Feb2021 at 09:30 (at 50-years-old). Relevant medical history included a known penicillin allergy. The patient denied being diagnosed with COVID-19 prior to receiving the vaccines. The patient denied receiving any other vaccine within four weeks of these vaccine or any other medications within two weeks; the patient was not pregnant at the time of vaccine. The patient reported that on 30Dec2021 she got COVID which required a visit to doctor or other healthcare professional office /clinic. A SARs-COV2 nasal swab was positive on 31Dec2021. There was no treatment received for the events. The outcome of the events COVID was recovering.
Approximately 2 hours after administration the patient had a seizure and was transported to the hospital. She was released that night.
Legs hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Legs hurt) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (Legs hurt). At the time of the report, PAIN IN EXTREMITY (Legs hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  The patient post receiving their Moderna dose of vaccine stated that their legs hurt.  No Concomitant product use was reported. No treatment information was provided.
Very dizzy, skin hurts, bones hurt, all joints (knees, ankles, elbows and entire spine) very painful, headache, fever, nauseous, muscle spasms in chest area and abdominal area as well as lower back. Hives on injection arm,  Loss of appetite. These symptoms lasted 3 days. October 26-28
This spontaneous report was received from a registered nurse concerning an unknown number of patients of unknown age and gender that were vaccinated with a dose of GARDASIL dose, dose number, lot number, expiration date and route were not reported, that was improperly stored. No adverse effect reported. Medical history and concurrent conditions were not reported. Co-suspect and concomitant therapies were not reported. This is one (1) of eight (8) reports from the same reporter. Additional information has been requested.
I tested positive for COVID-19 on 5/18/22. I had headache, fatigue, 1 day of fever, sore throat, extreme congestion, my ears were killing me. I am still dealing with ear congestion at this time.  I tested positive for 2 weeks.
Local swelling the night of administration but improved and resolved by 1/3. On the morning of 1/7, the injection site was again swollen and red, now with mild itching. Swelling worsened to a hard indurated area.
I started running a fever 101.8  and after 48 hours fever was gone. Swelling to my arm and my arm was pink.
Fever. Generalized arthralgia duration one week. Then resolved. Also, redness and tenderness at injection site.
Bump under arm in arm pit area; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 11May2021 at 14:45 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history included pulmonary embolism since 2004 and penicillin allergy. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date in Apr2021 at 14:45 (at the age of 39-year-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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13May2021 at 06:00 the patient experienced bump under arm in arm pit area. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included treatment with anti-inflammatory medication (unspecified). The clinical outcome of the event bump under arm in arm pit area was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
At 3 AM, 12 hours following the vaccine administration, I awoke with severe fever/chills, body aches and severe headache, which progressed to nausea and vomiting x 3 episodes and was very sick for one day, home bound and could not work.  This reaction was due to I believe the fact I had positive antibodies from a positive infection 8 months prior.  I had laboratory evidence of a positive serum antibody titer following the infection.  Was this vaccine studied in regards to patients who received the vaccine? because I believe it needs further study before it is given to patients who have already developed immunity from acquiring the actual COVID disease.
Patient received second dose of Moderna too soon. Patient had first dose of Moderna 11/19/21 and had not yet been 28 days.  The patient is aware of this issue and is scheduled to return to the Health Clinic on 1/7/22 for a repeat second dose.
At 8:00 PM I started having lower abdominal pain. It didn't go away and I suspected it could be an appendicitis so around 1:00 AM that night I called my internist and they said to go to hospital. I checked in to emergency room at  Hospital and they did a cat scan and confirmed it was an appendicitis. They transferred me to Hospital and I had my appendix removed around 11:00 AM
Large, red welt developed on right arm 8 days after vaccination administered. Welt is painless, but itchy and numb.
Shortly after 2nd vaccine patient developed local reaction with lymphadenopathy, then developed within a week a ropy painful vein extending to the wrist. Seen 1 month later, ultrasound in clinic with peripheral thrombosis of Left arm, no axillary or deep venous system thrombosis. No history of same. Given extent of thrombosis 45 days of anticoagulation for peripheral thrombosis prescribed.
Chills, fever, body started to ache, headache 6 hrs after I started with chills.  At 11 pm I took Ibuprofen 600mg and went to bed.  I woke up the next morning feeling fine.
The pt experienced a rash from the shoulder to the elbow with redness, muscle soreness, swelling and loss of range of motion.
Vaccine was given off label meant for 4-6 years old and was given to a 9 months old. No symptoms or adverse reactions known at this time.
Nurse inadvertently gave Pfizer Covid 19 vaccine dose that was beyond 6 hours from dilution.
Cellulitis of (L) upper arm w/ erythema and swelling to appx 2x the size of the (R) upper arm.
After first vaccine - I had a mild headache and than a migraine the next day. Felt normal after (03/17/21)  After the second vaccine - I had a mild headache and migraine the next day (04/07/21) I still have a mild headache today. After receiving the second dose, later that day I began to get a numb tongue on the left side which is still present. Along with tiredness.
Patient had her first dose of the COVID vaccine and was waiting in the lobby when she asked another patient to get help. When staff arrived she was grey, dizzy, having difficulty breathing with rapid respirations and overall not feeling well. Pulse Ox was 88 on room air so she was placed on oxygen and the EpiPen was used. EMS was called. She began improving with the oxygen and after the 0.3mg of Epi. EMS transported her to the ER and at her request her boyfriend was notified.
Information has been received from a licensed practical nurse concerning a currently 21 year old female patient who has an allergy to eggs and with a history of an allergic reaction when she was a child. When the patient was 18 months old she was vaccinated IM with a dose of MMR (second generation) (lot # not reported). Within one hour of receiving the vaccine the patient developed a severe rash and could not breathe (also reported as difficulty breathing). The patient was seen in the emergency room but was not admitted. She was sent home the same day with a lot of medications. It was not known what she was treated with. It was reported that the patient was now married and wanted to start a family. Lab evaluation revealed that her measles titer came back negative. Her physician requested that the patient receive a dose of MMR (second generation). It was reported that the patient was afraid to get since she is allergic to eggs and had allergic reaction when she was a child. Upon internal review, could not breathe was determined to be an other important medical event (OMIC). Additional information  has been requested.
Patient was 16 years old at the time of vaccination.  No adverse events known at this time.  No signs or symptoms of an allergic response observed during post vaccine observation period.
A patient was vaccinated with an expired PENTACEL vaccinations with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a physician via other health care professional via Medical Information  (Reference number- 00669933) and transmitted to Sanofi on 06-Jul-2021.  This case involves a 5 months old patient (unknown gender) who was vaccinated with an expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (Expired product administered)  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient had no other vaccines  On 05-Jul-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot UJ325AA, expiry date: 13-Jun-2021 and strength: 0.5 ml) via intramuscular route in the right thigh for prophylactic vaccination.  It was a case of an actual medication error due to Expired vaccine used (latency same day)  It was reported ''Medical assistant calling to report that (3) patients were given expired PENTACEL vaccinations on 5Jul2021''  At the time of report, no adverse event was reported.  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 the 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.
10:50pm mother heard gurgling noises from son in crib. Found son having a seizure in crib. Patient received 2nd series of vaccinations earlier that day. Mother immed. called 911 to ER. ER gave patient ATIVAN. Patient spiked 101 degrees. Fever after ATIVAN (no fever reported prior) and stopped breathing. Patient was intubated and placed on ventilator and flown to another hospital. Stayed at hospital until 6/8/13. Saw neurology, infectious disease, etc.
A nurse reported that a 33 year old female received an injection of Flu Shield '00-'01 on 11/15/00. Immediately, post vax, she developed a painful knot in her neck. She was treated with ibuprofen and it resolved after 3 hours. Later that day, she developed a swollen tongue and numb lips that "felt like pins and needles". She felt strange and became pale. She was treated with oral diphenhydramine. She recovered on 11/16/00. This is 1 of 3 pts from this facility who had an adverse experience following receipt of Flu Shield '00-'01, lot 4008176.
Vaccine was given too early.  1st dose- 10/28/2021 & 2nd dose- 11/29/2021