chrisvoncsefalvay/vaers-outcomes huggingface dataset:
First dose of Jynneos was administered intradermally; Case reference number US-BN-2022-003325 is a spontaneous case report initially received from a nurse via Company (reference number: USBAV22-1514) on 23-Sep-2022 and concerns a patient of unknown demographics.   The patient's medical history included keloids.  The patient's concomitant medication details were not provided.  On an unspecified day, the patient was vaccinated with the first dose of Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number: not provided), administered intradermally, at an unknown dose or site of administration, for monkeypox prophylaxis (explicitly coded as 'intradermal injection').   At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos.   Additional information received from Bavarian Nordic on 23-Sep-2022 included the local BN case ID.  This case is linked to cases US-BN-2022-003326, US-BN-2022-003327 and US-BN-2022-003328 (same reporter).; Reporter's Comments: A patient of unknown demographics was vaccinated with the first dose of Jynneos, administered intradermally, at an unknown dose or site of administration, for monkeypox prophylaxis, which is considered as intradermal injection. At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos. Intradermal injection is considered as listed per company convention. The patient's medical history included keloids and concomitant medication details were not provided. Intradermal injection has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with the first dose of Jynneos, administered intradermally, at an unknown dose or site of administration, for monkeypox prophylaxis, which is considered as intradermal injection. At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos. Intradermal injection is considered as listed per company convention. The patient's medical history included keloids and concomitant medication details were not provided. Intradermal injection has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
COVID vaccination Pfizer 2/23/21 and 3/16/2021. Thrombocytopenia, Platelet level 3/31/21 149, recheck on 4/19/2021 104. Asymptomatic.
Miscarriage. Was early 1st trimester, estimated delivery date was supposed to be November 2021. Had one 2 sucessful pregnancies and no miscarriages before.
The pharmacist inserted the needle into my arm on an angle and it felt like the tip was hitting my bone. It hurt. I don't normally have pain from a shot except for the initial pinch sensation, but this pain continued after the insertion. I don't know if the needle slipped or if he did not pinch enough muscle, but it was an incompetent shot. I believe he placed the needle in the wrong place. I was fine for about 3 hours, then my arm turned red and swollen, and where the needle went in on an angle, there was severe pain. It left like a pinched nerve. The redness and swelling lasted for a full three days, and the first evening it was difficult to sleep from the severe pain in my arm. I applied ice, voltaren and took ibuprofen.
Information has been received from a certified medical assistant concerning a 14 year old female who was vaccinated with a first dose of GARDASIL and experienced syncope.  She was taken to an emergency room and released.  The patient was vaccinated with a second dose of GARDASIL (unspecified time).  Subsequently, the patient experienced her first seizure (unspecified time) and was taken to the emergency room (no further details provided).  The patient was vaccinated with a third dose of GARDASIL at 15 years old.  Approximately 27-JUN-2008, two weeks after the third dose, the patient developed a complication.  She was taken to the hospital by ambulance but passed away during the transport from an unknown cause.  The physician has asked the mother for the autopsy report.  The reporting medical assistant considered the syncope, seizure and "a complication" were considered to be immediately life-threatening and disabling.  Additional information has been requested.  2/13/09 Autopsy report received.  COD:  Seizure Disorder. Summary Diagnoses: Clinical history of seizure disorder.  Pulmonary congestion and edema.  Passive visceral congestion.  2/20/2009 ER received from CDC. Pt presented to ER via EMS following witnessed seizure activity with fall from standing. Upon EMS arrival pt had agonal respirations and was pulseless in V-fib at 650. Upon arrival in ER unresponsive, pupils fixed and dilated, no cardiac activity. Resuscitation unsuccessful and pt expired.
Nosebleed started around 11 pm that night.  Got another a week after. I have never gotten a nosebleed before.
had a migraine type of headache,body aches could not sleep so bad, that night(10/20/2021) my lower part of arms and legs went numb and tingly, that lasted about 16hrs on and off. on 10/21/2021 around 300p my spine was hurting and extreme hotness went from my lower part of spine to the base of my head(brought tears to my eyes) that pain was on and off til 10/22/2021 around 700p the headache and body aches lessened but did not go completely away until 10:00 on the 10/23/2021 i have not seeked medical help so far but all has been reported to my work place and i was told it was doumented.
Sore arm; fatigued; foggy; Off balance; Diarrhea; Short of breath; chest tightness; dysautonomia; Low BP readings to high BP readings; Feel crummy; High heart rate days 7 onward post vaccine.; High blood pressure; This is a spontaneous report from a contactable consumer or other non hcp. A 54-years-old non pregnant female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/lot number: Not Known, Expiration Date: not reported), dose 1 via an unspecified route of administration, administered in Arm Right on (Age at vaccination 54 Years) 28Jul2021 11:45 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included blood pressure increased, covid-19 from 27Jul2020 to an unknown date recovered. Concomitant medication(s) included telmisartan (TELMISARTAN) taken for blood pressure measurement. Prior to vaccination, patient diagnosed with COVID-19. Since the vaccination, patient was not been tested for COVID-19. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccin. The patient received other medications within 2 weeks of vaccination is Blood pressure med telemesartan. Clinical course follows as 19 days post vaccine symptoms. I have long covid and this flared my long covid.  First three days were textbook symptoms. Sore arm, fatigued, foggy.  Then starting days 5 onward I literally went through long covid again.  Blood pressure seriously went crazy day 8 onward past vax.  Low BP readings to high BP readings.  Bottom number the systolic moved up 10-18 points for 10 days.  Heart rate increased. About 15 points for 2 weeks.  And I'm on blood pressure medication!!!!    Felt dysautonomia return.  Off balance post shot 1 for a week.  Diarrhea for a few days.  Short of breath returned for 2 days.  Then chest tightness returned for 4 days.  Still have a little.  No this was not psychological.  This was real. Very real.  Start of day 19 post vaccine I'm starting to feel a bit more like Pre vaccine baseline. On 29Jul2021 12:00, The patient experienced high heart rate days 7 onward post vaccine, high blood pressure, On Aug2021, feel crummy and low bp readings to high bp readings, dysautonomia, On 01Aug2021, sore arm, fatigued, foggy, off balance, diarrhea, short of breath, chest tightness. The patient underwent lab tests and procedures which included antibody test: none on I had antibodies going into the vaccine with a lab Corp semi quantitative Covid antibody titer score of 18 going into shot 1, sars-cov-2 test: positive on 27Jul2020. No treatment was received. AE resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events high heart rate days 7 onward post vaccine, high blood pressure, feel crummy was not recovered and remaining events are recovering.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up
pt recvd vax 23MAR95 & pt reported to MD that during the noc (w/in 12hrs) upper arm (immunized arm) became swollen & painful;had low grade fever & flu-like sx described as myalgias & malaise;No MD visit;no prior h/o pneumococcal infect
This spontaneous report as received from a registered nurse refers to a 9 month old male patient. On 01-OCT-2008 the patient was vaccinated with the first dose of VARIVAX (Merck) (lot #, route and dose not reported) when he was under 12 months of age. On 12-MAR-2009, the patient was subsequently administered the second dose of VARIVAX (Merck) (lot # route and dose not reported). No adverse effect reported. It was unknown if the patient sought medical attention or not. Additional information has been requested.
pt recvd vax & lost strength in arms; taken to hosp; pt was dx w/ guillain barre synd;
The patient  presented today for routine 6mo WCC and vaccines w/ flu and covid vaccine as well. After immunizations were administered and documentation was being completed I realized the Moderna 6mo-5yr primary series vaccine expired on 04/13/2023. Patient and mother had already left the clinic when this error was realized.
In late January and beginning of February I started to feel a lot of neurological symptoms. I had strange sensations in my arms. I was having tiny muscle twitching in my body. I was having night sweats. I was also having hyper aware sensations in my nerves. I was also having trembling. I also was having muscle weakness. I have also had a tremor in my face that was got even worse over the last two years. That was diagnosed as a benign intentional tremor. My muscle ache and my joints hurt. I have an appointment with a rheumatologist.
Pain in same shoulder as vaccination, which was administered high on the deltoid. Pain increased daily.  Steroid injection done on 11/09/2011.  Physical therapy 11/23/2011 for 4 weeks.   Pain continues to this day.
This spontaneous report as received from a medical assistant refers to a 55 year old female patient with no medical history or drug reaction/allergies. On 21-JAN-2014, the patient was vaccinated with ZOSTAVAX vial, subcutaneous, single dose (lot # J011339 exp. Date 13-DEC-2014). There was no concomitant medication. On 22-JAN-2014, the patient developed redness, swelling, pain and warmth at the injection site, and treated herself with BENADRYL. On 23-JAN-2014, the patient was evaluated in the office, it was noted that the area of reaction was about the size of a 50 cent piece. The patient was treated with Dexamethasone injection (manufacturer unknown). On 24-JAN-2014, the patient called the office and reported that the pain was decreasing but the redness was extended down her arm. The patient was prescribed Doxycycline and a Prednisone (manufacturer unkonwn) dose pack. At the time of the report the patient was recovering from swelling, pain and warmth of injection site. No lab diagnostics were performed. IT was noted that the medical assistant was requesting a lot check. Additional information has been requested.
New onset seizure. Total of 4; This is a spontaneous report from a contactable consumer (patient).   A 32-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in left arm on 02Apr2021 07:00, at the age of 32-years-old, (Lot Number: ER8737) as DOSE 1, SINGLE; and via an unspecified route of administration, administered in right arm on 23Apr2021 07:00 (Lot Number: EW0171) as DOSE 2, SINGLE for covid-19 immunisation.  Medical history included seizure on 01Apr2021 05:00AM. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.  On unspecified date on Apr2021, after receiving the vaccine, patient had new onset seizure, total of 4. The event required ER visit, and the patient was hospitalized for 2 days due to this.  Post vaccination, the patient been tested for COVID-19, tested with nasal swab with negative result on 24Apr2021. The outcome of the event was recovering.    Information on Lot/Batch number was available. Additional information has been requested.
Information has been received from a pharmacist referring to multiple patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored ZOSTAVAX (lot # L046897, expiration date 23-FEB-2016; dose and route were unknown). No adverse effects were reported. The temperature excursion included 30 minutes at -11.6 Celsius degree, 2 hours and 30 minutes at -8.7 Celsius degree, 1 hour and 30 minutes at -9.2 Celsius degree, 1 hour and 15 minutes at -9.8 Celsius degree. Data logger was involved. There was no previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Trying to stay hydrated; noticed a bit of pinkish red when he went to the bathroom; He woke up with a lot of pain / renal pain; kidney stone; This is a spontaneous report received from a contactable consumer (patient). This 28-year-old Male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot: EW0172, Expiry: 31Aug2021) via an unspecified route of administration, administered in left upper arm as single dose for COVID-19 immunisation on 24Apr2021.  The patient medical history included seasonal allergies (From Unspecified to Ongoing) around 10 or 11 years old and allergic with tree pollen mainly, cedar trees and animal fur (usually took Tylenol, Claritin and Zyrtec). The patient concomitant medications included 10mg oral cetirizine hydrochloride (ZYRTEC) for seasonal allergies so that he can breathe normally.  Patient was diagnosed with kidney stone on 24Apr2021, same day evening when he got the first Covid-19 vaccine. The patient was trying to stay hydrated, noticed a bit of pinkish red when he went to the bathroom, he thought it was just a side effect. Woke up with a lot of pain and after some testing, they told him he had a kidney stone. He was fighting a kidney stone and taking medication for span of time between first covid-19 vaccination and second vaccination. He doesn't think it is related. The doctor gave a couple medications just for monitoring things, the next day after 13May2021, he went for a CT and haven't felt anything since from the kidney stone.  Prior to vaccination, patient was not diagnosed with COVID-19.  Since the vaccination, the patient not been tested for COVID-19.  Treatment therapy included 0.4mg oral tamsulosin HCL taken for kidney stone from 03May2021 to 13May2021, hydrocodone and acetaminophen taken for renal pain from 03May2021 to 13May2021 (patient only took when he was in drastic pain (pain for kidney stone). Not as a daily medication). The outcome of event kidney stone was resolved on 13May2021. The outcome of other events was unknown.
This spontaneous report received from a patient concerned a White male of unspecified age and ethnic origin. 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 (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 201A21A expiry: unknown) dose was not reported, 1 total, administered on left arm on 10-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in SEP-2021, 4 to 6 months after primary vaccination, the patient started experiencing severe muscle soreness, about one inch under the skin of the injection site, felt like someone hit in that area and felt like there was a bruise inside the skin, but could not physically see it (all events with dose number in series 1). Patient stated at the time of reporting that it was little worse. The patient had not recovered from severe muscle soreness under the skin about one inch at vaccination site, and felt like bruising inside the skin. The patient received additional booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (unspecified manufacturer) (suspension for injection, route of admin not reported, batch number and expiry date were not reported) dose was not reported, 1 total, administered on  11-NOV-2021 for prophylactic vaccination. No adverse events were observed following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was non-serious.
flu like reaction; Fever; Chills; Bad Aches; congestion that lasted 2 full days; This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd February 2020, the patient received the 1st dose of Shingrix. On 2nd February 2020, immediately after receiving Shingrix, the patient experienced influenza-like symptoms, fever, chills, pain and nasal congestion. On an unknown date, the outcome of the influenza-like symptoms, fever, chills, pain and nasal congestion were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, fever, chills, pain and nasal congestion to be related to Shingrix.  Additional details were provided as follows: Minutes after vaccination the patient had flu like reaction, fever, chills, bad aches, congestion that lasted 2 full days. Batch number and expiration date were not reported as she did not received first dose in the same facility that she worked in. The reporter consented to follow up.
I have taken Pfizer-BioNTech COVID-19 Vaccine EUA  Three days later I have muscle pain, ear infection, headache, stomach very up set, feeling not well
77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; The doses were administered before it was known if the vaccine was ok to use after the excursion; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (The doses were administered before it was known if the vaccine was ok to use after the excursion) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (The doses were administered before it was known if the vaccine was ok to use after the excursion) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (The doses were administered before it was known if the vaccine was ok to use after the excursion) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and POOR QUALITY PRODUCT ADMINISTERED (The doses were administered before it was known if the vaccine was ok to use after the excursion).    No concomitant medication was reported.  No treatment medication was reported.  This case was related to patient number 8 out of 77.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Patient received the vaccine on Wed 4/7/21 @945am and about a week later she started to experience itchiness, red, hot to touch and a lump feeling at the injection site along with pain at the site radiating down to elbow and up to the shoulder. Patient took benadryl on 4/15/21 around 930am and she states it didn't help.  No fever, body aches or chills. Advised patient to take tylenol or ibuprofen for the pain, and she can also apply benadryl cream or hydrocortisone cream to help with itchyness. Advised if patient experiences any chest pain or sob then to go to urgent care or ER. 4/16-***PharmD*** Placed follow up call on 4/16/2021 at 12:06pm: Pt reported that she feels a little fatigue today. She also reports the right arm is still really red and swollen, and still have big knot but not as itchy today. The bump is still hot to the touch, and pain still radiates from her right elbow up to her shoulder when that arm is being touched. Pt reported she had appliced ice pack in the beginning for approx. 10-15 minutes on and off, but still had no relieve. Pt also reported that she took Tylenol, Benadryl, and applied cortizone cream as recommended on her initial call and that still did not help (except cortizone cream helped some with the itchiness). Pt advised she was not able to get an appt with her MD, but MD has sent prescription to pharmacy (pt not sure what rx was sent over).   ***NOTE*** Recommend pt that if her symptoms did not get better to go to urgent care if she is not able to get into see her MD. Advised pt will follow up with her on Monday 4/19/2021 after giving her a couples of days to see if the rx the MD prescribed provide any relief, or if her symptoms resolve by then.
PT stated she took her 2nd covid shot, pfizer, and had a mini stroke. PT a bicuspid valve heart since birth. She can get too hot and hyper ventilate. Since stroke she has had limp using cane can't write as well. Patient did consent to follow up.
Swollen Right Shoulder; This spontaneous case was reported by a patient and describes the occurrence of SWELLING (Swollen Right Shoulder) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced SWELLING (Swollen Right Shoulder). At the time of the report, SWELLING (Swollen Right Shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Prevnar vaccine given and later same day developed diarrhea and vomiting with fever 101.2
Yesterday I started to notice pain/soreness on my arm, neck and armpit and today I felt and now see a rash/lump the size of my fist. It is red in color and warm to the touch. I also have another small bump/rash under my arm. My neck and arm are sore  and feel a bit tingly.
Painful erection. Pain radiates from base of penis and is especially painful just prior to ejaculation. Never once have I had this symptom before.