chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender (encounter key #235027). The patient's concurrent conditions and medical history were not provided. On 20-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (VIs 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) single dose, route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, PNEUMOVAX had a temperature excursion for 40 and 72 hours, the lowest recorded temperature was 28F (-2.222 Celsius) and the highest was 47F (8.333 Celsius). The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
pt recvd vax 9NOV92 & seen 12JUN94 w/ lt parotid gland swelling dx mumps; pt recvd initial MMR vax 6DEC89;
Kidney stone 12/26/2020 followed by salivary gland stone 1/2/2021 Narrative:
Pain in muscle at injection site which has worsened and persisted for more than two months.  It is ongoing and interferes with sleep and prevents normal activities
patient received the QUADRACEL vaccine instead of the PENTACEL vaccine by accident with no reported adverse event.; Initial information received on 22-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 months old male patient who received the diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] instead of the Pentacel vaccine by accident with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Prophylactic vaccination; and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Prophylactic vaccination.  On 02-Jun-2022, the patient received 0.5ml dose of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine, (formulation: unknown) (lot C5862BA; expiry date; 01-Apr-2023; strength and not reported) via intramuscular route in the right thigh for prophylactic vaccination.  On 02-Jun-2022,the patient received the quadracel vaccine instead of the pentacel vaccine by accident with no reported adverse event (wrong product administered) (same day latency).  It was asked if the child should get a separate HIB injection and what would the proper diluent be.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE (QUADRACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the event (patient received the QUADRACEL vaccine instead of the PENTACEL vaccine by accident with no reported adverse event.).  At time of reporting, the outcome was Unknown for the event patient received the quadracel vaccine instead of the pentacel vaccine by accident with no reported 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 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.
I had absolutely NO side effects on this 6th vaccination.  The previous 5 vaccinations resulted in a sore arm for about 3 days and other mild symptoms.  This one did nothing of the sort.  I then read about pharmacists having issues with management that leads to patient endangerment leading to possible walkouts by the pharmacy staff.  I am suspicious that the vaccine administered to me was not viable, possibly due to storage problems.
In the hours following the inoculation, I was becoming increasingly fatigued. Approximately 11 hours after inoculation, I developed a very high fever (temperature unknown), moderate headache, muscle and joint pain, and delirium.
Pfizer-BioNTech COVID-19 Vaccine EUA  Approximately three weeks after this injection, I began to feel a pain in my left leg.  I assumed it was a cramp. I then received a second dose (Lot # EN6206) on 3/13/21.  Over that weekend the pain in my leg grew worse and the leg began to swell. on 3/15, I went to my primary care physician who said it looked like a blood clot. He sent me to a radiologist for an ultrasound (?) of the leg. After confirming the clot, I went to a local ER. They started me on Eliquis to treat the clot
Patient had second vaccination on 2/19, and later in the evening started to feel achy, and tired, and had swelling under arm, that is still there, though it has gone done. She satted it feels like it spread to her breast. She also stated she had a twitching on the side of her mouth that lasted a second. She denies, fever, SOB, chest pain, rash, or any other symptoms. She stated she is taking Tylenol every 6 hours which is helping. RN reviewed red flags to call 911. RN reviewed would folllow up tomorrow with her.
he got both doses of the Pfizer COVID vaccine back in Jan2021. He got COVID in August; he got both doses of the Pfizer COVID vaccine back in Jan2021. He got COVID in August; This is a spontaneous report from a contactable consumer(patient).  An 81-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Jan2021, as single dose (Batch/Lot number was not reported) and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Jan2021, as single dose (Batch/Lot number was not reported) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient stated he got two shots of the Pfizer covid vaccine back in Jan2021. In early Aug2021 he got COVID and the doctor suggested to get a regeneron infusion which he did get. Since he got the two doses in Jan2021 and he got the regeneron in Aug2021, he was asking if he should get the booster. The patient had a physician office visit and got treatment for all events included regeneron infusion. The patient underwent lab tests and procedures which included Covid: positive in Aug2021. The outcome of all events was unknown.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Patient's boyfriend called today reporting side effects from Moderna Covid vaccine.  He said she is really suffering today.  He said she is feeling really weak and it is hard for her to move much, her arm hurts badly, she has a fever and has vomited and had a headache.  I apologized that this was happening.  These side effects can happen with the vaccine, but they also sounded more severe than normal.  I told him if she is really suffering, she may want to get seen by a doctor, but also recommended pushing lots of fluids to stay hydrated and to try to eat some comfort foods if she can tolerate them, as well as tylenol.  I also mentioned that the side effects normally last for a day or 2.
On 2/1/01, pt's left thigh was swollen and red. Treated with cold compresses initially and then warm compresses after 24 hours.
Tetanus reaction. Patient received her tetanus shot on March 8th. She initially just noted a little bit of redness and pain at the site but not too bad for several days. On the 12th, in the evening she noted that her third, fourth, and fifth digits on her right hand, the arm she got her tetanus shot in, were numb and tingly and upper arm and armpit, breast area was quite swollen and tender, She also noted a large red mark below the site of injection. She initially tried some Benadryl, ibuprofen 800 mg, cold compresses, etc. and was able to get some sleep that first night. By yesterday, however 800 mg of ibuprofen ongoing and regular Benadryl was not helping; in fact her pain and swelling is getting worse. She called out clinic and was recommended to come in for evaluation. Today, she feels things are little bit better although she now is noting some pain extending up into her neck and face and just a general funny feeling around her shoulder blade, her neck, and her face. She denies any fevers, chills. She denies any new skin changes. She denies any injuries to this area. She denies any symptoms in her lower extremities or her left arm and is otherwise feeling well. No nausea or vomiting. She had a good appetite, etc. No weakness in her right arm just pain. She has been able to continue to work. Allergies to Codeine and Morphine.  04/23/2007 VAERS report submitted with medical records attached. Several OVs including 2 Neuro consults.  1st OV of 3/15/2007 Pt c/o numbness and tingling in the 3rd, 4th, and 5th digits of the R hand, the arm she got her tetanus shot in. Swelling and tenderness noted in the R upper arm, armpit, and breast area.  pain progressed into her neck, face and shoulder blade.  No weakness or skin changes noted.  Report of 3/21/2007 shows pain and swelling improved, however now having pain and cold sensation around shoulder blade radiating to neck and upper back. Neurology consult 3/27/2007 shows no evidence of any focal neuritis or radiculopathy.  Impression:  Likely an allergic reaction to Adacel. 2nd Neuro consult 4/5/07 with Assessment of Brachial Neuritis which chronology suggests was a reaction to tetanus shot. 01/12/2010 Pt has ongoing Brachial Neuritis & severe pain. hse is on Neucontin & Ambien. Inaddition she has been getting stellate nerve blocks every month with sore pain relief.
Several minutes after receiving the vaccine, the patient began to feel dizziness, and her throat began to tighten up.  She then developed pruritis (generalized), a rash that was described as urticarial on the anterior neck.  She said she also developed some chest tightness, but then described it as more in the upper back.  She did not receive any medications for this--she appeared to be spontaneously improving in the ER.  She said that she felt tired and foggy.
Patient is 17 y/o at time of vaccination. He was under the age of recommendation set forth by the manufacturer.  No reaction to the vaccine observed or reported by the patient.
vasovagal reaction, sweating, dizziness, pallor, heart palpitation, did not faint
Lips swell , tong Swell, gums were numb  . patient was given EpiPen on site
Vaccine recipient (H1N1) described a raised, pimply, prickly rash noted on both forearms and stomach.
Havrix given 3 months apart; This case was reported by a pharmacist via sales rep and described the occurrence of drug dose administration interval too short in a male patient who received HAV (Havrix) for prophylaxis.   On an unknown date, the patient received Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 15-DEC-2022 Reporter's comment: The pharmacist noticed when the patient came in to get Havrix that on state registry that the patient was given dose of Havrix three months apart instead of six. The reporter consented to follow up. Additional supportive information: The patient received the dose of Havrix earlier than the recommended interval, which led to shortening of vaccination schedule.
Fever 101.2 and sorethroat at school, nurse called mother, taken to doctor
Pt. got sick in the middle of the night after receiving his second vaccine. He had a fever, chills, body aches. He is a very physically fit teenager who is active in weight lifting, football and wrestling. His blood pressure is now high, and he has had 9 nose bleeds in 11 days. Currently his pediatrician, Dr. is tracking his blood pressure. He has not fully recovered and still appears ill after his vaccine. Blood tests have been requested, but orders have not been issued yet.
Intense body aches with headache and nausea. Patient was not able to eat or drink anything except water during the episode. No fever, no congestion, no coughing or SOB. Symptoms lasted for 36 to 40 hours.
Approx. 5 hrs post receiving MMR, developed swollen lips, swollen eyelids, hives on neck; Did not take medication; Did not seek medical care, Sx subsided-1 pm next day
first dose two years ago, not yet received 2nd; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 2 years ago, 50 microgram).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient's husband. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
1-6-21 Fatigue, nausea 1-7-21 T. 99.6, lethargic, unresponsive   to hospital
This case was reported by an employee of a healthcare facility via a sales representative and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of KINRIX (unknown). At an unspecified time after vaccination with KINRIX, the subject experienced injection site redness and swelling injection site. At the time of reporting the outcome of the events was unspecified. The sales representative had limited information. The sales representative was told that the adverse events were noticed with three separate subjects on different dates. The injections were given by different nurses. Please see A0877765A and A0877778A for the two additional reports of injection site redness and swelling injection site.
Patient received 1st booster on 10/6/2021 at a hospital. County came to their living facility and administered another booster dose on 11/3/2021.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 62-year-old male patient received BNT162b2 (BNT162B2), on 12Feb2021 at 14:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 61 years, in left arm for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: now testing positive; Negative, notes: Continue to test negative till day 14. Clinical course: Paxlovid work great seven days later patient tested negative, continue to test negative till day 8 after the symptoms. Continue to test negative till day 14 now testing positive. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Feeling unwell; This spontaneous case was reported by an other and describes the occurrence of MALAISE (Feeling unwell) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On 29-Apr-2021, the patient experienced MALAISE (Feeling unwell). At the time of the report, MALAISE (Feeling unwell) was resolving.            Action taken with mRNA-1273 in response to the events was not applicable.
Patient developed a 7 x 7 cm. round, raised warm area distal to injection site.
Severe migraine headache could not tolerate light or sound.  Nausea with no appetite.  Diarhea and muscle weakness.  All adverse reactions lasted for 36 hours from the start time.  Ibuprofen ,Tylenol and Maxalt were taken to try to relieve the pain.  Symptoms were gone after the 36 hour period.
Her arm was swollen and red. She reported she a a knot the size of a golf ball.
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L039141, expiration date 16-AUG-2017; lot # M004890, expiration date 10-NOV-2017, dose not reported) orally. The doses of vaccine were improperly stored at 34 degree Fahrenheit for 228.5 hours. There were no previous excursions. No data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt was given 0.5 ml of influenza vaccine instead of 0.25 ml. Called CDC was told dose counts and possible positive local reaction. 10-31-07 no reaction per parents.
severe headaches; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (severe headaches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced HEADACHE (severe headaches). At the time of the report, HEADACHE (severe headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment information provided.
10 min after MMR given started itching - 0925AM. 25mg BENADRYL given PO per Dr - 0935AM. 0940AM - Wheezing, c/o throat tightness, taken to Emergency room.
1035 After approx 10 min of receiving shot, noted redness to R deltoid with redness to neck area. No resp. difficulty or other c/o. VS - 100/78, pulse 102, T 98.3. 1040 administered 1 shot of liq. BENADRYL. Tolerated well. 1047 rechecked redness, gone to neck area. 122/75, 98, T 97.7. 1110 all redness resolved. Released to mom and dad.
Talked with mother of minor and said she is doing well and has had no side affects.  Let mother know her daughter should not receive the second dose and she stated understanding of this. Reviewed error with nurse and she thought she had calculated correctly.  Reviewed process for verifying age. Registration form has been corrected so patient has to write their actual age and birthdate.
Sense of taste has been affected/  taste buds were markedly dulled at breakfast Sunday morning/Sense of taste still has not returned. The difference between her sense of taste before and after 2nd shot is substantial; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Fc3182) via an unspecified route of administration in the left arm on 28Aug2021 at 17:45 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. Medical history included fibromyalgia, nickel sensitivity, serious side effects from some medications; internal bleeding and hyponatremia. Prior to 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. The patient did not receive any new medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Fc3180) via an unspecified route of administration in the left arm on 07Aug2021 at 17:45 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. On 29Aug2021 at 09:00, the patient experienced sense of taste has been affected. The patient received 2nd shot at approximately 18:00 on Saturday, and was shocked to find that the taste buds were markedly dulled at breakfast Sunday morning. It was reported that the patient was writing this at 06:00 Tuesday morning and the sense of taste still has not returned. The difference between her sense of taste before and after the 2nd shot is substantial, which alarms the patient. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sense of taste has been affected/ taste buds were markedly dulled at breakfast Sunday morning/Sense of taste still has not returned. The difference between her sense of taste before and after 2nd shot is substantial were not resolved at the time of this report.
Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. The patients' pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patients were vaccinated with doses of VAQTA (lot # J005010 with expiration date 23-OCT-2015 and lot # L004743 with expiration date 01-JUN-2017; dose, route and dose number were not reported) which were exposed to temperatures outside of the recommended range. No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
Dizziness, headache, vomiting, diarrhea, Lethargy, syncopal episode
Complaining of itching. Mother saw a few spots more spots/ bumps developed as week progressed. Mother brought child to see pediatrician 4/15/04pm.
On the morning of Friday, April 16th I began to feel tingling in my fingers, like pins and needles, and weakness in my hand. It lasted the entire day and through the next day.  It felt very numb and like I was having neurological damage. It was in the opposite arm that I had received my Moderna shot.
10/12/07 Patient developed a reaction to Hib + Prev (both given in same leg). The leg swelled to twice its size with redness and pain after 6 hrs developed 103 fever and vomited.