chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist (who was also the one of the two patients) via company representative refers to 2 patints of unknown age and gender. Approximately on an unknown date in May 2013, the patients were vaccinated with a dose of ZOSTAVAX (lot # J000853, expiry date was 23-APR-2014, route and dose were not reported) that had been accidentally left in the refrigerator for a week. The reporter had had enquired about this and was told that it was OK to use this vaccine during the next three months. Approximately on an unknown date in May 2013, (reported as the week of 12-MAY-2013, 3 days after vaccination), the patients broke out in large, painful hives, broke out with rash and welts. One of the patient who was a pharmacy technician had described the pain as being similar to a bee sting. No medical attention was sought. No treatment was provided for the event painful hives. The outcome of all the reported events was unknown. Additional information has been requested.
Started a bad earache from my right ear that I had injured long ago. Flushed rash on face, neck, chest, and red ear. Also had a low grade fever 99.9-100.9  extremely fatigued,  after a few days I noticed joints aching. Especially shoulders, elbows, knees, and sometimes wrist. I thought I must have gotten sick but I was under quarantine because my daughter had just had a kidney transplant donated by her sister. They noticed I started having memory fog and had a hard time when concentrating. My care for them was difficult because of feeling week and so tired but I just pushed myself.  The second immunization was everything magnified.
Red, raised bump at injection site. Warm to the touch and itchy. No pain, though injection site was achy for a few days post-injection.
Patient suffered acute STEMI . Was being escorted to medical when he became unresponsive , CPR  was initiated immediately; AED was placed  and "shocke advised". Patient recieved shock and  became alert within 15 seconds. ASA Nitro and NS given. EKG showed 5 elevation infanct. Patient transported to hospital. STENT placed.
4 x 3 cm Reddened with lump under skin. Bruise in center. Fever of 100.
pt was given expired vaccine 12/31/21, per Pfizer RN  expired vaccines are good for up to 32 days max. spoke with  who is medical informaition at Pfizer and recommend to contact CDC. spoke with  at cdc and recommended to re-vaccinate as soon as possible spoke with pt and pt does not have s/sx of adverse effects at this time.
3/23 normal fatigue and arm pain, 3/24 woke up with body aches, 99 fever and it hurt to breath, between this day to the 27 there was an increase in pain in breathing, every breath it hurt. and still having pain breathing; I'm on a high dose of Prednisone
Headache, NauseaVomiting, chills, pain on site of injection Narrative:
vaccine dose was prepared from vial that has been stored in freezer at -25c to -15c for a total of 19 days which is 2 days over allowed time frame of temperature excursion of pfizer ( 17 days)
Sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (patient had them on my right upper leg and hip).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Sore arm). The outcome of the pain in arm was resolved (duration 3 days).   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 17-MAR-2023 This case was reported by a patient via interactive digital media. The patient had them on her/his right upper leg and hip. It was bad but patient make sure not to scratch.  The patient got the shot and only had a sore arm for 3 days. The follow-up could not be possible as no contact details were available.
Patient described pain in the deltoid after inoculation stating it felt like she had been punched.
Receives first pre exposure rabies vaccine 6/23/2004 11:55AM. Developed itching, redness, swelling soft fatty tissue posterior to bicep right arm (vaccine was given IM)-deltoid. Itching, redness, swelling: lasted 3 hours at that time began declining. Remained local reaction only. Has similar reaction to allergy shots he receives on Mondays and Thursdays
Pt started with chills, then developed 101 F fever, also had sweats, fatigue
Sore arm, Chills, Weak, Dizziness from 4/27, 3 AM till noon. Still have sore arm with a couple of pink patches on upper arm area.
Extreme headache started about 24 hours after vaccine.  Patient also has complains of nausea and vomiting.  (He normally eats 5 eggs for breakfast but could only eat 2 eggs.)  He didn't see anyone or take anything for the headache.  It seemed to ger better slowly and in 4 days it was gone.
A report has been received from a Health Professional concerning a 10 year old, Male subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on an unknown date. The patient received expired FLUMIST quadrivalent which started on 05-Feb-2015. The outcome of the event of patient received expired FLUMIST quadrivalent is unknown. The report was considered to be non-serious.
Site of injection start to hurt; Fever; Slight discomfort; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Slight discomfort), VACCINATION SITE PAIN (Site of injection start to hurt) and PYREXIA (Fever) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DISCOMFORT (Slight discomfort). On 18-Nov-2021, the patient experienced VACCINATION SITE PAIN (Site of injection start to hurt) and PYREXIA (Fever). At the time of the report, DISCOMFORT (Slight discomfort), VACCINATION SITE PAIN (Site of injection start to hurt) and PYREXIA (Fever) outcome was unknown.            No Concomitant product use was reported. No treatment information was provided. Patient wants to know if it's ok to take aspirin for the fever or ibuprofen for the pain.
Patient received a TDAP vaccination on 2-10-17 and noted axillary lymph node swelling on 2-13-17.
The pt received oral Typhoid on 3/12/13. She delayed the first dose until 3/14/13 because she ahd a low grade fever (no other associated symptoms). She took the 3rd dose on 3/18/13 at 0700. At 0800 she noted a flat, red, itchy, "splotchy" rash (lesions were about 3mm) on her left arm (wrist to shoulder). She also noted nausea (no vomiting, or diarrhea) and throat "irritation" which she described as her throat "closing". This sensation laed to her feeling" which she described as her throat "closing". This sensation lead to her feeling the need to clear her throat frequently--she denied SOB or difficulty swallowing. The pt does not recall consuming any unusual foods or drink--in fact she has consumed the same food/drink since this time without similar symptoms. The pt does note that the rash is similar to the rash that she gets immediately after coming in contact with grass although this does not cause the sensation that her throat is closing. Also, the rash that she experiences after contact with grass typically occurs within 2 hours and resolves within 10-12 hours without treatment. The pt went to medical for evaluation of her symptoms and according to the pt she was told to increase her fluid intake which she did and the symptoms resolved within 48 hours. The pt was instructed not to take dose #4.
Area where shot given red itching 11-24-09, 12-14-2009.  Rash circle around where shot was given.  Dr seen pt on 12-30-09 he stated child had reaction to H1N1 vaccine per mother.
Red area at injection site 3cm x 7 cm - hard to touch at center. Increased fussiness, crying.
Stomach issues; A red patch about 3-4 inches beneath the injection site; Headache; This non-serious case was reported by a consumer via call center representative and described the occurrence of upset stomach in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26-MAY-2023, the patient received the 2nd dose of Shingrix (left arm). In MAY-2023, an unknown time after receiving Shingrix, the patient experienced upset stomach (Verbatim: Stomach issues), skin red (Verbatim: A red patch about 3-4 inches beneath the injection site) and headache (Verbatim: Headache). The outcome of the upset stomach, skin red and headache were resolved.   It was unknown if the reporter considered the upset stomach, skin red and headache to be related to Shingrix.     It was unknown if the company considered the upset stomach, skin red and headache to be related to Shingrix.   Additional Information: Additional Information: GSK Receipt Date: 30-MAY-2023 The patient self reported this case. The patient received Shingrix and developed a headache, a red patch about 3-4 inches beneath the injection site and stomach issues.  The symptoms were resolved in May 2023 after the 2nd or 3rd day.  The reporter did not consent to follow up.
On October 11, 2021 I experienced intense pain beside nose, possibly ethnoid. Pain continued mostly at night Oct 12-13 On October 14 the pain was sharp and shooting into forehead, right side only. On Oct 15-16 chewing caused excruciating pain in forehead. On Monday Oct 18 called primary care physician who sent me to ER, where following CT scans of head I was diagnosed with Trigeminal neuralgia and prescribed Carbamazepine. On Oct 19 saw ENT who scoped nasal passages and found no cause. I was referred to neurology. On Oct 26 following extensive neurology exam the Trigeminal neuralgia diagnosis was confirmed.
Information has been received from a physician concerning a 16 year old female who on 08-AUG-2007 was vaccinated with a dose of Gardasil. On 08-AUG-2007 the patient experienced bilateral knee pain and knee swelling. The physician aspirated fluid from the patient's knee and reported there was no infection. However the physician states he saw pyrophosphate crystals in the fluid from the knee which he stated "is rare in younger people". At the time of the report the patient was recovering from bilateral knee pain and knee swelling. It was noted that lab test were performed. The reporting physician considered bilateral knee pain and knee swelling to be disabling. Additional information has been requested.
soreness around the injection site, hot to the touch, swelling from half way down to the elbow to up and over the shoulder blade, thick feeling tongue, inability to raise the arm
This initial spontaneous report was received from a lawyer regarding a case in litigation concerning an adult patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date in 2006, the patient was inoculated, in a Medical Center, with a dose of ZOSTAVAX as recommended for routine adult health maintenance and for the long-term prevention of shingles (strength, route, anatomical location, dose number, lot/batch # and expiration date were not reported). On an unknown date in 2008, the patient was treated, by the Urgent Care, for the onset of a vesicular rash, which was diagnosed as shingles. The vaccine did not prevent shingles as intended, and subsequently contracted a persistent strain of herpes zoster or shingles (vaccination failure). As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages (injury), and required extensive medical care and treatment. As a further proximate result, the patient had suffered and would continue to suffer significant medical expenses, and pain and suffering (emotional distress), and other damages (injury). At the time of reporting, the outcome of vaccination failure, herpes zoster, emotional distress, injury and pain was unknown. The reporter considered all the events to be related to ZOSTAVAX.
2 days after receiving her month shots she started having small seizures. Her seizures got longer In length and more frequent. 5 days later she was having 14 seizures. She was rushed to the ER where they diagnosed her with epileptic seizures. She was put on keppra which didn?t help. 2 months later was switched to trileptol.
This spontaneous report as received from a nurse refers to a 4 year old patient, of unknown gender. Patient's current conditions, medical history, concomitant medications, drugs allergies or reactions were not reported. On 18-MAR-2019, the patient was vaccinated with improperly stored dose of the following vaccine: PROQUAD, lot # R022568, expiration date 04-FEB-2020, (strength, dose, dose number, route and anatomical location were not provided) for prophylaxis. No improperly stored sterile diluent used was reported. The vaccine was exposed to a temperature of 6 Fahrenheit degrees to 14 Fahrenheit degrees (12.9 Fahrenheit degrees) for 66 minutes. There was a previous temperature excursion from 6 Fahrenheit degrees to 14 Fahrenheit degrees (12.0 Fahrenheit degrees) for 35 minutes. It was reported that digital data logger was involved. No adverse effects were reported. This case is one of six same reporter cases. Sender's Comments: US-009507513-1903USA011573; US-009507513-1903USA011572; US-009507513-1903USA011571; US-009507513-1903USA011574; US-009507513-1903USA011570.
This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a 20-year-old female patient who received BEXSERO (batch number 16D601, expiry date unknown) for prophylaxis. On 12th June 2018, the patient received the 1st dose of BEXSERO. On an unknown date, less than a month after receiving BEXSERO, the patient experienced injection site pain and injection site swelling. On an unknown date, the outcome of the injection site pain and injection site swelling were recovered/resolved. It was unknown if the reporter considered the injection site pain and injection site swelling to be related to BEXSERO. Additional details were provided as follows: This case was reported by an office staff. The patient received BEXSERO on the left arm. The reporter agreed to be contacted for follow up. For tolerance to next dose, refer case US2018GSK134428.
This spontaneous report was received from a pharmacist regarding to a patient of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided. On 26-SEP-2018, the patient was inadvertently vaccinated with 1 dose of ZOSTAVAX, lot # N025569, with expiration date 13-DEC-2018 (strength, anatomical location or route of administration were not provided), for prophylaxis; which was previously reconstituted with sterile diluent (MRK), lot # M044951 with expiration date 07-JUL-2019; instead of VARIVAX (wrong drug administered). No adverse effects were reported.
Vado-vagal episode. Blood pressure plummeted. Sweating, nausea. Resolved in 30 minutes
No adverse effects reported; received improperly stored doses of VAQTA; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient' s concurrent conditions, medical history and concomitant medications were not reported. On 10-APR-2019, the patient received improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) lot # R025518, expiration date: 15-NOV-2019, for prophylaxis (exact dose, frequency and route of administration were not provided). The vaccine underwent temperature excursion of the lowest temperature of 36 degrees Fahrenheit/ 2 degrees Celsius (34F) for 1 hour and 17 minutes and the highest temperature of 47 degrees Fahrenheit/ 9 degrees Celsius (50F) for 30 minutes. There was no previous temperature excursion. The digital data logger was not involved in recording excursion details. No adverse effects were reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA005734:
inadvertently received a dose of MENQUADFI instead of TRUMEMBA With no reported adverse event; Initial information was received on 08-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 17 years old male patient who stated inadvertently received a dose of meningococcal a-c-y-w135 (t conj) vaccine [Menquadfi] instead of trumemba 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 suspect meningococcal a-c-y-w135 (t conj) vaccine solution for injection lot number not reported via unknown route in unknown administration site (strength, dosage, frequency, expiry date: unknown) for immunisation.  On an unknown date the patient developed a non-serious event of inadvertently received a dose of menquadfi instead of trumemba with no reported adverse event (wrong product administered) (unknown latency) following the administration of meningococcal a-c-y-w135 (t conj) vaccine.  Action taken with meningococcal vaccine (Menquadfi) was not applicable.  At time of reporting, the outcome was Unknown for the event inadvertently received a dose of menquadfi instead of trumemba 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 guidelines. 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.
Information has been received from a pharmacist referring to a patient of unknown age and gender. On 12-JAN-2016 the patient was inadvertently administered improperly stored ZOSTAVAX (lot # L027321 with expiration date: 21-OCT02016 or lot # L035283 with expiration date: 15-DEC-2016, route and dose were unknown). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Headache, Myalgia, CoughWheeze, Chills, sweats Narrative:
Sore arm; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and PYREXIA (fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant details were provide
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Jun2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 48 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Pulmonary emboli" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "chronic urticaria" (unspecified if ongoing); "PCOS" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS; CRESTOR; TRULICITY; OMEPRAZOLE; JARDIANCE; METFORMIN; SPIRONOLACTONE; VITAMIN D 3; FISH OIL; BASAGLAR; XOLAIR; VITAMIN B NOS. Past drug history included: Lisinopril, reaction(s): "Known allergies: Lisinopril". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Body temperature: (30Jun2022) 98.7; (01Jul2022) 97; SARS-CoV-2 test: (unspecified date) Unknown results; (unspecified date) Positive; (27Jun2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: Concomitants administered within 2 weeks of vaccine. On 22Jun2022, she started Paxlovid for treatment of COVID-19. Patient took her last treatment of Paxlovid on Sunday, 26Jun2022. She tested negative for COVID-19 on Monday, 27Jun (Day 9 after onset of symptoms). She had adverse event on 29Jun2022 at 06:15 am and given unknown treatment. Had a follow-up with her primary care on Wednesday, 29Jun and was given a clean bill of health. Thursday night (30Jun), she felt a bit warm, but temperature was 98.7. On 01Jul2022 (Friday), she woke up still feeling a bit warm, but temperature was only 97. Her throat feels a bit scratchy and so she decided to take a COVID-19 test and tested positive again.
Vaccinated on 07/23/2020 with Trumenba. Patient woke up on morning of 07/26/2020 (3 days post-immunization) and was unable to lift his right arm (not the same arm as injection site). Mother was able to lift patient's arm to assess mobility range and patient did not complain of any pain. Mother gave ibuprofen throughout the day on 07/26 with no improvement. Mother states that patient is not able to lift arm to lift a fork or to drive as some examples. Mother is going to try Benadryl and if no improvement, will return to clinic for further evaluation.
Started with h.a., progressed to N/V and muscle aches x 2 days.
Arm and leg on side of vaccination became so painful unable to put on clothes. After 24 hrs then resolved spontaneously.
pt recvd vax & mom reported pt was fussy all afternoon p/vax; crying progressed uncontrollable late evening around 11PM on MN; slep sporadically during the noc;  mom noticed pt was red & breaking out in hives; pt seen by MD; tx Antihistamin