chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a health care worker refers to unspecified number of patients of unknown age. The patients were vaccinated with GARDASIL in 2008. No other co-suspects were reported. No concomitant medications were reported. The patients experienced fainting after receiving GARDASIL in 2008. These events happened at an unspecified facility where the healthcare worker was employed at that time. The outcome of the patients was unknown. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Redness, swelling. Assessed 24 hours post vaccine, appeared to be resolving, however at 30 hours post vaccine vaccine redness and swelling worsened (cellulitis) prescribed for augmentin BID x 7 days.  Patient has been icing and elevating, will continue. Advised to seek care at EMERGENCY ROOM if worsens.
Patient came in for a booster vaccine, they had Janssen originally and had a reaction where their tongue started swelling and they had trouble swallowing. They were given 2 Benadryls when that happened and were monitored until they were better. It was thought to be a speicific component of the Janssen vaccine that wasn't in the Moderna vaccine so she had it recommended to her that she should get the Moderna this time. The same thing happened with tongue swelling and trouble breathing about 10 minutes after administration, patient took 2 Benadryls again, was monitored fro about 30 minutes then left.
low mumps titer; This spontaneous report has been received from a physician referring to an approximately 57 years old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy information was not provided.   On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live manufacturer unknown (strength, dose, frequency, route, lot # and expiration date were not reported) for prophylaxis.            The patient was serologically tested in recent past (week of 13-MAY-2019) based on recent measles outbreak circumstances. Titer results revealed low mumps titer and didn't show low measles titer. No treatment was given for the event. On an unspecified date in May 2019, the patient recovered from the event.  The causality between the event and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live manufacturer unknown was not provided.  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA008993: US-009507513-1906USA004734:
I developed intense shaking throat my entire body  This lasted for abut 45 minutes?uncontrollable  I had similar episode after my second vaccination
Apprehension, dizziness  11:30am 136/80  80  02sat 99%;   11:42am  130/77  80  02sat 98%;  12:04pm  125/80  70  02sat 99%; Gave patient snack and water.
18 Month old accidentally given Tdap (GSK - Boostrix) instead of Tripedia (DTaP) no side effects at all.
Stiffness; Did not allow him to fall asleep; Joint pain; Slight elevated fever; Splitting headache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness), INSOMNIA (Did not allow him to fall asleep), ARTHRALGIA (Joint pain), PYREXIA (Slight elevated fever) and HEADACHE (Splitting headache) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. HRSA014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness), INSOMNIA (Did not allow him to fall asleep), ARTHRALGIA (Joint pain), PYREXIA (Slight elevated fever) and HEADACHE (Splitting headache). The patient was treated with IBUPROFEN on 22-Apr-2021 at a dose of 1 dosage form. At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiffness), INSOMNIA (Did not allow him to fall asleep), ARTHRALGIA (Joint pain), PYREXIA (Slight elevated fever) and HEADACHE (Splitting headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
migraine type headache, severe at times dizzy, felt like head was in a tunnel and unable to clear it; migraine type headache, severe at times dizzy, felt like head was in a tunnel and unable to clear it; migraine type headache, severe at times dizzy, felt like head was in a tunnel and unable to clear it; This is a spontaneous report from a contactable 57-year-old male other health care professional reported for himself. A 57-years-old male patient started to receive second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284), via an unspecified route of administration at Left arm on 07Jan2021 at SINGLE DOSE for covid-19 immunization. Medical history included pinched nerve in left leg and kidney stones (recovered). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685) Intramuscular at Left arm on 17Dec2020 04:00 PM for covid-19 immunization. The patient experienced migraine type headache, severe at times dizzy, felt like head was in a tunnel and unable to clear it. it had been going on since second dose and got worse, not sure if can continue work. The event started on 08Jan2021 02:00 AM, no treatment received for the adverse events. The events were reported as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No allergies to medications, food, or other products. The outcome of the event was not recovered.
This case was reported by a nurse via call center representative and described the occurrence of fever in a 51-year-old female patient who received SHINGRIX (batch number 7X3EJ, expiry date 13th October 2020) for prophylaxis. Co-suspect products included INFLUENZA VACCINE (SANOFI PASTEUR) for prophylaxis. On 17th August 2018, the patient received SHINGRIX and SANOFI PASTEUR SEASONAL INFLUENZA VACCINE. On an unknown date, several days after receiving SHINGRIX, the patient experienced fever, chills, headache and tingling sensation. The patient was treated with ibuprofen and TYLENOL. On an unknown date, the outcome of the fever, chills, headache and tingling sensation were not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, headache and tingling sensation to be related to Shingrix.  Additional details were provided as follows: The health care professional reported that the patient received Shingrix on arm. On the same day of Shingrix administration, the patient received flu shot by Sanofi in the alternate arm. Possibly within a few days after receiving Shingrix, the patient experienced internal fever and chills, headache and tingling sensation across back. The symptoms had not resolved and appear to intensify during the evenings. The patient was self treating the symptoms with ibuprofen, Tylenol, warm showers for chills and cool packs during feverish moments. It was unknown if the reporter considered the fever, chills, headache and tingling sensation to be related to Flu vaccine. No further information reported regarding the event.
Hives beginning near vaccine site on upper right arm around 8 hours after vaccine, spreading around upper right arm, right shoulder, left arm, knees. Still experiencing hives 4 days later. Very itchy. Treating with other hydrocortisone and oral benadryl.
I began to experience spotting that eventually turned into menstruation.; I began to experience spotting that eventually turned into menstruation.; Its now day 12 and it has not stopped.; Its now day 12 and it has not stopped.; This is a spontaneous report from a contactable other hcp (Patient). A 38-years-old non pregnant female patient received (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number: Ew0168) via an unspecified route of administration, administered in Arm Left on 17Aug2021 14:15 pm (At the age of 38 years) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  She had no known allergies. She did not receive any other vaccines in four weeks. Prior to vaccination, she was not tested for covid. She was not tested to covid post vaccination. On 18Aug2021, after 24 hours post injection the patient experienced "i began to experience spotting that eventually turned into menstruation" "Its now day 12 and it has not stopped". She did not receive treatment for the adverse events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Information has been received from a physician via a field representative referring to a male patient of unknown age. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX for prophylaxis (dose, route and lot# were not reported). On an unknown date, after the patient received ZOSTAVAX, the patient developed shingles (unspecified location). The outcome of herpes zoster was unknown. The relationship between the event and ZOSTAVAX were not reported. Additional information has been requested.
Information has been received from a physician concerning a 13 year old female who on an unspecified date was vaccinated with Gardasil.  Eight days post vaccination, the patient experienced black marks or spots on both hands.  She sought medical attention.  She returned to the physician's for a follow-up visit.  She went to the emergency room, but no details were available.  Additional information has been requested.
2 days after shot I developed a brain fog feeling.  Felt disconnected from world.  Unable to focus and concentrate.  Concerned for my safety driving.  This continued for 2 weeks.  Saw a doctor to check bloodwork and make sure nothing else was wrong.  After 2 weeks the symptoms transitioned from fogginess to dizziness.  This has continued till now (at 3 weeks post Moderna shot number one).  Room seems to spin when sitting still or closing eyes.  Dizziness occurs throughout day, although not consistent.  Bloodwork results all came back normal.  Physical exam normal.
pain at the injection site, headache, muscle soreness, fatigue, fever and chills. Chills began the following day in the afternoon and fever came down within ~6 hours. By midnight I had recovered from all adverse events.
Family traveling to home. Pt became unresponsive and was foaming at the mouth. This lasted < 5 min, about 40 min, later she vomited. Short time later was acting fine. Sent to ER for eval., EEG is being ordered.
Information has been received from a registered nurse concerning a patient's uncle who on an unspecified date was vaccinated with MMR II. Subsequently, the patient developed idiopathic thrombocytopenic purpura. It was unspecified if medical attention was sought, or if lab studies were performed. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Upon internal review idiopathic thrombocytopenic purpura was considered other important medical event. No further information is available.
Migraine; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from a sales representative.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MIGRAINE (non-serious), outcome "unknown". The event "migraine" required physician office visit. Therapeutic measures were taken as a result of migraine.  Additional information: It was reported that she was being treated by a neurologist. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Left arm with erythema and edema approximately 4 X 6 cm, warmth to area.
First dose on 21-Sep-2020, second on 16-Mar-2021; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a patient who received HAV (Havrix) for prophylaxis.   Previously administered products included Havrix (received the first dose of Havrix on 21st September 2020).   On 16th March 2021, the patient received the 2nd dose of Havrix. On 16th March 2021, 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: 20-SEP-2022 Reporter's Comment: The office manager to confirm the situation and get more information.  The reporter contact information was sent by email. The reporter accepted follow up. Additional Supportive Information: The patient received 2nd dose of Havrix earlier than the recommended schedule, which led to shortening of vaccination schedule.
Vaccine administered BUD (on day 32); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered BUD (on day 32)) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered BUD (on day 32)). On 16-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered BUD (on day 32)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant product were reported. No treatment information was provided.   This case was linked to MOD21-127424, MOD21-128279 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Oct-2021: Follow up was received on 04-OCT-2021. Contains Dose 1 administration date.
Developed pox on the 23rd of August.  Went to hospital today 8/30/08. Legs, chest and back covered approx. 50% with pox. Doctor affirmed it was pox covering his body.
Information has been received from a health professional concerning a 26 year old female with a history of asthma, hypothyroidism and anxiety, who on 17-MAY-2007 was vaccinated IM with the third dose of Gardasil vaccine (Lot # 657736/0389U). There was no concomitant medication. On 18-JUN-2007, the patient experience nodule and tenderness at injection site, tender 3 in. down arm. Subsequently, the patient recovered from the nodule and tenderness at the injection site, tender 3 in. down arm. No product quality complaint was involved. No further information is available.
patient complained of itchiness on arm about 10 minutes after shot was given in the same arm. pt was assessed and given 0.3 cc of 1:1000 Epinephrine chloride subcutaneously in the opposite arm. patient's itchiness was relieved.
Grandma phoned PHN 5/21 1PM-states that child has fever 102-103 (ax), vomiting x 6, fussy, no sleep since returned home 5/20 after shots, trying to give H20, Kool-aid-not eating; trying to give Tylenol, "not herself". PHN instructed to phone Dr. for recommendations. PL 5/24 4:30PM Grandma states that they had a call into Dr, but was not returned. "Child has not insurance". Relates  that fussiness, emesis 2 more times and fever 102-103 (ax) con't through Sat. Sat PM ate popsicles, no emesis -Sun. AM "back to herself".
On 2/20/2019 my arm was swollen and red and warm to the touch about the size of a softball. It was painful to touch and with movement (similar to the tetanus shot). On 2/21 I started to feel achy all over, feverish and headache - like the flu with general body aches and chills. My arm was increasingly sore to touch and with movement. I was generally out of commission for any activity except basic activity of daily life - feverish, chills, muscle aches, headache - laid around. I felt flushed but was freezing. 2/22/19 - feeling a bit better but still achy with headache and occasional  chills. My arm was no more swollen, but still red and hot to the touch - the size of large softball. 2/23/19 - I felt more normal but my arm was reddened from upper arm to approx. 1 inch above elbow. The reddened area was rash like, warm and started to itch. 2/24/19 I felt okay overall - achiness in body gone. My arm was less sore but remains painful to touch and the redness spread more and area was bumpy and itchy. 2/25/19 - Area of redness has decreased in color intensity and size has decreased a bit. It is still sore to touch but movement pain has decreased.
Headache, Myalgia, NauseaVomiting, fatigue, chills
Broke out in hives on head/back & arms. Face turned red. Injection site swollen/hard & red for 5 days following.
Patient had a big bruise at the site of injection. It was a little hot at the touch. And when touching it with pressure it was painful.
I started to get itchy all over my body. My eyes started to swell up and get puffy. Now I have red itchy spots from my neck to my feet and I am still itchy
Myalgias, erythematous rash that started on 8/28/11, a few days after 8/24/11 vaccine left arm. Given antibiotic.
Tonic-clonic seizure.  Jerking extremities, urinary incontinence, duskiness of lips, face and hands, gurgling respirations, no memory of events, rigidity, tongue biting.
Patient received Hep A in right arm. Then received HPV in left arm. C/O pain & numbness. Started walking down hall fainted and had tonic/clonic movement for 15 sec.
patients received a vaccine that under went a temperature excursion; No adverse event; patients received a vaccine that under went a temperature excursion; This spontaneous case was reported by a medical assistant and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patients received a vaccine that under went a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (patients received a vaccine that under went a temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Aug-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients received a vaccine that under went a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients received a vaccine that under went a temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patients received a vaccine that under went a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (patients received a vaccine that under went a temperature excursion) 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 POOR QUALITY PRODUCT ADMINISTERED (patients received a vaccine that under went a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients received a vaccine that under went a temperature excursion).    Patient's weight was reported as 29. Vaccine administration site was reported as LQ. Concomitant medication list was not provided.  It was reported that Moderna COVID-19 vaccine experienced one temperature excursion. Some vaccine was stored in the freezer and other vials in the refrigerator. 38 patients received Moderna COVID-19 vaccine that underwent one of two temperature excursions either in the freezer or refrigerator depending on where the vaccine was stored at the time of the temperature excursion. The excursions were picked up by state review of the temperature data logger 2 weeks later after the excursion. Storage condition at the time of the excursion was refrigerated storage. Date vial was moved from freezer to refrigerator was 08-Aug-2022. Maximum or minimum temperatures reached, as applicable was positive 14 degrees Celsius. Excursion duration was 3 hours and 5 minutes. They were administered and discarded. Proposed desired Use by date was 18-Aug-2022. Number of vials/ per doses impacted was 1 vial.  The excursion occurred on 07-Aug-2022.  The vials were not punctured until they were used for a patient and then discarded. No side effects were reported. Treatment information was not provided.
p/vax pt devel chronic vomiting & a few loose stools;pt was afeb;pt hosp10/99;unspecified tests were negative;pt was discharged from the hosp;pt exp a dec appetite & weight loss;pt re-hosp 11/9/99;dx failure to thrive;
BODY ACHES; CHILLS; FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced body aches, chills, and fatigue. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, body aches, and fatigue. This report was non-serious.
Still have a little muscle; Still have a little joint; This case was reported by a consumer via interactive digital media and described the occurrence of muscle discomfort in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (the patients niece had shingles the worst painful experience in her life and never ever go through that again).   In August 2022, the patient received Shingles vaccine. In August 2022, less than a day after receiving Shingles vaccine, the patient experienced muscle discomfort and discomfort in joints. On an unknown date, the outcome of the muscle discomfort and discomfort in joints were not recovered/not resolved.   It was unknown if the reporter considered the muscle discomfort and discomfort in joints to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-Aug-2022 Reporter's Comments: The patient self-reported this case via interactive digital media. The patient got the Shingles shot a few days ago from reporting, the side effects were tough to take on the first night it diminished the next day still had a little muscle and joint. The patient was sure it goes away soon. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Whole body aches started at 6pm 3/9. Took Tylenol and slept. Aches finally stopped at 3pm 3/10. Worst aches in legs, back, and chest.  Extreme fatigue set in at 3pm 3/9. Slept off and on. Finally stopped feeling extremely tired at 8pm 3/10.  Ears felt plugged around 6pm 3/9 and still feel plugged today 3/11.