chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a staff member administered FLUZONE QIV NP to a 10 week old patient instead of Prevnar with no reported adverse event; FLUZONE QIV NP is not approved for use in patients less than 6 months old; and admintered FLUZONE QIV NP to 10 week old patients with no reported adverse event; Initial information received on 18-Mar-2022 regarding an unsolicited valid  non-serious case received from a non-healthcare professional.  This case involves a 2 months old and unknown gender patient who was administered Influenza quadrivaL A-B vaccine [Fluzone QIV] instead of Prevnar which is not approved for use in patients less than 6 months old with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza quadrivaL A-B vaccine (with an unknown formulation, strength, dose and route) (lot number: UT7407AM and expiry date: 30-Jun-2022) in unknown administration site for prophylactic immunization.  On an unknown date the patient was administered Influenza quadrivaL A-B vaccine instead of Prevnar with no reported adverse event (wrong product administered) and Influenza quadrivaL A-B vaccine is not approved for use in patients less than 6 months old with no reported adverse event (product use issue).  Action taken was not applicable.  Outcome: Unknown    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.
She had severe mental distress, paranoia and anxiety with severe depression which has gradually abated until today (6/14/21) she is off additional medication.
shingles, after having the first shingles shot; Didn't have the second; This case was reported by a consumer via  interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox and shingles (had 2 times).   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported for 1st dose and not applicable for 2nd dose. The patient received 1st dose of Shingles vaccine and experienced shingles. Till the time of reporting, the patient did not have the second shot, which led to incomplete course of vaccination. The patient was not for sure about everybody getting the shot. The follow-up would not possible as no contact details were available.
Mild to light red rash to arms, thighs, sides and neck. Non vesicular. Itches.
Vaccine expired on 20-May-2022 and stored in refrigerator on 07-Jun-2022 and administered on 08-Jun-2022; No adverse event; Patient administerd booster dose of expired Moderna Covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administerd booster dose of expired Moderna Covid-19 vaccine), PRODUCT STORAGE ERROR (Vaccine expired on 20-May-2022 and stored in refrigerator on 07-Jun-2022 and administered on 08-Jun-2022) and NO ADVERSE EVENT (No adverse event) in a 79-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administerd booster dose of expired Moderna Covid-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 20-May-2022 and stored in refrigerator on 07-Jun-2022 and administered on 08-Jun-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administerd booster dose of expired Moderna Covid-19 vaccine), PRODUCT STORAGE ERROR (Vaccine expired on 20-May-2022 and stored in refrigerator on 07-Jun-2022 and administered on 08-Jun-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administerd booster dose of expired Moderna Covid-19 vaccine) and PRODUCT STORAGE ERROR (Vaccine expired on 20-May-2022 and stored in refrigerator on 07-Jun-2022 and administered on 08-Jun-2022).    No concomitant medications were reported.  The patient received booster dose.  It was reported that the medical assistant saw that the expiration date was 20-Jun-2022 when looked that up before however medical assistant had nothing in writing or printed to confirm the expiration date of 20-Jun-2022. Patient received Moderna Covid-19 vaccine that was expired and past the Manufacturers expiration date.  It was reported that the vial was initially stored in the refrigerator on 07-Jun-2022. The vial did not undergo any temperature excursions.  The patient did not experienced any adverse events.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2022: Live follow up received contains product dose details added. Expiry date updated. On 02-Sep-2022: Live follow up received contains non significant information.
01/21/2021 - Rash and itching of left upper arm and left shoulder blade for about 3 months. About 07/15/2021 - start of tingling of hands progressing to numbness then to loss of blood flow to hands resulting in white cold hands (this occurred in feet also but was not as bad).      It has not yet improved and is sometimes quite painful.    Symptoms I think are identical to Raynaud's or cold agglutinins.
pt recvd flu vax & following dialysis pt devel hypotension & loss of consciousness; 1 liter IV saline was administered & pt was hospitalized;
BP 102/60, P 70, O2Sat 98%.  As client walking to the observation room he passed out for a few seconds.  Complained of dizziness.  Assisted with ENT to observation.  Stabilized after few minutes.
Painful shot; itching in the arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In APR-2023, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: Painful shot) and itchy upper limbs (Verbatim: itching in the arm). The outcome of the pain and itchy upper limbs were resolved.   It was unknown if the reporter considered the pain and itchy upper limbs to be related to Shingrix.     It was unknown if the company considered the pain and itchy upper limbs to be related to Shingrix.   Additional Information: GSK receipt date: 17-Aug-2023 and 19-Aug-2023 The patient had the first Shingrix shot and was a painful shot. After couple weeks, the patient developed severe itching in the arm and went on for 2 to 3 weeks and now only slightly itches and it was manageable. The patient was very concerned about this side effect and asked that have you gotten any other complaints like that. The patient did not know for sure if it was caused by the shot, but it seems to radiate from the site of the injection.  Neither the primary care provider or dermatologist knows the answer and suggested the patient contact the company to see if they had this problem with any other patients. If they could provide information, it will help her to decide whether to get the second shot. The caller was not sure the patient will get the second Shingrix vaccine.  The patient would like to know if anyone else has had this happen.  Gave medical information number for health care professional to call but the patient declined to provide health care professional contact information.
red in area in the injection site; arm has been noticeably swollen; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (wife). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received the second dose of the covid vaccine and since then, the wife had been having red in area in the injection site that resolved yesterday of about 6x4 inches and her arm had been noticeably swollen. He said that they have a little card but lost it about what to do in cases like this and so they called to know what they should be doing. The outcome of the event red in area in the injection site was resolved on unspecified date and her arm had been noticeably swollen was unknown.  Follow-up attempts are completed. No further information is expected.
This spontaneous case, initially received on 18-Oct-2018, reported by other healthcare professional (nurse), concerns a 22-year-old adult female patient. The patient did not receive any concomitant medications. On 15-Oct-2018 (Monday), the patient was administered FLUCELVAX QIVc [ dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252234 and expiry date: 30-Jun-2019]. On 16-Oct-2018 (Tuesday), 1 day after vaccination, the patient developed a red, warm and hard area at the injection site. The patient received ibuprofen, BENADRYL and put cold compresses. But treatment medications did not relieve the symptoms. It was reported that, the patient was not hospitalized. At the time of this report, the patient had not yet recovered from the events. The reporter assessed this case as non-serious.
Child was seen in ER on 9-2-16. Diagnosed with hand, foot and mouth. Child was taken by mom to ER on 9-4-16 because no better. Temp 102.4 and rash that started on abdomen and back. CXR showed possible right lower lobe infiltrate suggestive of Pneumonia. Given Prednisolone and Augmentin by ER.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) by a physician's assistant, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2016, the patient was treated by the physician's assistant for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
fever of 105 mom states did not go to MD;pt in to hlth dept on 19NOV97 & told us what had occurred;
Received expired dose of the vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired dose of the vaccine) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired dose of the vaccine). On 05-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired dose of the vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was provided. No treatment medication details was provided.   This case was linked to MOD-2021-342886 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Oct-2021: Follow up received, contains no new information.
She got her vaccine, she did not have any reactions other than the soreness of the arm when she touched it.  Then five days later she had a serious nose bleed like water gushing out of a faucet.  She put her head back to stop the bleeding.  She had 3 on 4/5/2021, then had 1 on 4/8/21, 2 on 4/10/21, 2 on 4/11/21, and then on 4/12/21 they finally lightened up and then on 4/13/21 she was okay and has had none since.  The only that she did was put her neck back, squeeze her nose and then sat up.  It was about an hour between intervals before the bleeding would stop.  She called her ENT and when she called them she left her name and phone, but they have not called back yet.
patient was given expired dose of Tenivac/ no adverse event; Initial information was received on 02-Feb-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a male patient of unknown age who was vaccinated with expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (batch number not reported and expiry date 28-Jan-2021) via an unknown route at an unknown administration site for prophylactic vaccination (expired product administered).  Caller wanted to know if they should re-vaccinate or it was okay with the expired dose.  It was a case of actual medication error due to expired vaccine used (latency was on same day).  At the time of report, no adverse event reported.  Result of assessment was not 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 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.  There will be no information available on batch number for this case.  Inquiry retrieved from proxy. Outbound call attempt made: No answer, Left voicemail message requesting a call back. Note: No direct contact with HCP. Product used : Used
Patient has a history of fainting after vaccination. Patient told us prior to vaccination. Patient did not pass out but needed to lay down and put her legs on a chair.  She was a give a ice pack for her forehead. She recovered  after 5 to 10 minutes and reported back to work without any problems.
Area where vaccine given on arm is red, hot, firm, painful to touch, and swollen, with size of induration being about baseball size. Swelling started on evening of 10/17 and area if induration was much larger on the morning of 10/18. Swelling on 10/19 has not increased but has stayed the same as 10/18.
Induration a vaccine site approximately 5 in x 6 in at upper arm.  Warm to touch, tender.
Pfizer 12/21/20, 1/11/21, 10/22/21. Positive on 7/7/22
At site of Varivax vaccine about 1 wk. later, patient developed a bump and then a vesicular lesion (mom took picture w/ cell phone) Then developed vesicular lesions on back.
I woke  up with a feeling that my heart wanted to jump out of my chest. This was at 2am. I had a headache and began wondering what my BP was.. It was 190/112. In the morning I called my primary care provider. She advised me to go to the ER.. I did. Systolic pressure at that time was 181, headache persisitng. I was treated with clonidine and tylenol
10/2/12 rec'd Zostavax - sore at the site with a lump by 5PM same day. Red-hot, itching. throbbing. 10/2 it really bothered her a nurse friend "marked" the induration site. 10/5 redness went way beyond markings. Went to ER - Dx with cellulitis placed on 4 day prednisone taper and 7 days Keflex. 10/6 started med's-pharmacy was closed on 10/5. 10/7 Feels much better. No c/o any other issues.
Severe Acne, weight gain, cyst inside ovaries, Severe pain in ovaries, scared about effect of not able to have children from cyst damage, severe UTIs, nausea from pain, missing school & work because of pain....
A mother reported that her 6 year old son received a dose of Flumist on 12/12/03 and developed a cough and wheezing. The pt's concurrent medical history includes reactive airway disease and a "tendency to wheeze with any upper respiratory illness." Past medical history includes respiratory syncytial virus at 4 months of age and pneumonia. The pt received an intranasal dose of FLuMist on 12/12/03. Indication was immunization. Concomitant medication included unspecified vitamins. No other vaccines were administered on the day the pt received the FLuMist vaccine. On 12/12/03, the child developed coughing after the administration of FluMist. The reporter indicated that the "coughing became deeper" and on 12/15/03, the child developed wheezing. On 12/16/03, the child was seen by a physician and was prescribed Zithromas. As of 12/22/03, the coughing and the wheezing had subsided. This event was considered medically important (OMIC). No additional info was available at the time of this report.
Same day as vaccine, slight nausea & muscle ache. Eight days later, sudden onset of intense chills, low grade fever, muscle aches, headache, extreme sleepiness, no appetite - classic flu symptions. Most symptoms gone within 24 hours, except for headache, slight muscle aches, drowsiness, lack of appetite.
Arm pain that moved to shoulder. I currently still have should pain, especially with movement. Was send at Dr. office for treatment on 10/4/22. Was prescribed Naproxen 500mg. It didn't work. As I started I still have the shoulder pain. I have  SIRVA.
Arm very sore ~12 hours after injection. Chills, hot sweats, body aches, and headache through the night unable to sleep due to side effects. Day after vaccine achy and tired. 2 days after vaccine feel back to normal.
Muscle weakness; Difficulty walking; runny nose; aches; pains; Fever 101; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Muscle weakness), GAIT DISTURBANCE (Difficulty walking), RHINORRHOEA (runny nose), PAIN (aches) and PAIN (pains) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020. Previously administered products included for an unreported indication: MONOCLONAL ANTIBODIES (Received Bamlanibimab neutralizing antibody treatment.) on 28-Dec-2020.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCULAR WEAKNESS (Muscle weakness), GAIT DISTURBANCE (Difficulty walking), RHINORRHOEA (runny nose), PAIN (aches), PAIN (pains) and PYREXIA (Fever 101). At the time of the report, MUSCULAR WEAKNESS (Muscle weakness), GAIT DISTURBANCE (Difficulty walking), RHINORRHOEA (runny nose), PAIN (aches), PAIN (pains) and PYREXIA (Fever 101) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant  information was  provided. No Treatment information was  provided.
COVID ARM. AFTER FIRST DOSE. NOTICED A GRAPE SIZED, HARD BUMP AND IT FELT ITCHY. IT GREW PRETTY QUICKLY TOOK OVER AT LEAST HALF MY ARM. ITCHY. I TOOK BENADRYL THE LAST FEW DAYS BEFORE IT WENT AWAY AND APPLIED CORTIZONE ONTO AREA. ICED AREA. I STILL HAVE A DISCOLORATION ON MY ARM WHERE THE RASH WASH. IT'S LIKE A LIGHT BROWN OUTLINE OF WHERE THE RASH WAS.
fleeting chest pain; sore arm; Normal flu like symptoms; This is a spontaneous report from a contactable consumer.  A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced fleeting chest pain, sore arm, Normal flu like symptoms. It was reported that with this first dose he had just a fleeting chest pain, sore arm, the normal flu like symptoms along with that. He just called me, he had it yesterday, and he had low grade fever and the tiredness which was expected, so this morning he went in to work, it started with a headache and he said he is having some chest pain again, is that one of the normal side effects?" The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
This is a spontaneous report received from a contactable reporter (pharmacist). A 44-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown), single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. The patient experienced an ineffective drug (medically significant); COVID-19/she received the Pfizer primary series, then she contracted COVID-19 (medically significant), with outcome of unknown. The patient underwent the following laboratory tests and procedures: COVID-19 test: positive. The batch/lot number for BNT162B2 not provided and will be requested during follow-up. Sender's comments: Lack of effect is defined as absence of the intended clinical or pharmacological effect of a drug. For vaccine, the lack of effect, reported as COVID-19, is considered a listed event.
Parent found unresponsive around 4 am, arrived at Hospital at 4:46 am, pronounced dead at 4:48 am.