chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After the vaccine,  right away I fainted.  I felt a rush through my body and my eyes rolled back and my body was shaking.  I did not stay asleep for long and came back within seconds.  I layed on the ground and was shaking for 10-15 minutes.    This was all happening in the vaccination area.  A  nurse came and took my blood pressure and gave me orange juice and snack and a jacket since I felt very cold.  They also checked my vitals.  I was there for about 45 minutes and I was feeling better and allowed to go home.  I am still getting panic attacks.  Its the same feeling I am getting when I fainted.  I feel a rush through my body and I start to hyperventilate and trouble breathing followed by shaking and feeling cold.  This has happened 4 times since getting the vaccine.  I also had a headache, fever, sore throat and cough.  My extremities in my feet  muscle feels like its twitching.  My arm is still sore from the vaccine. I  do have an appt coming up with my PCP.  My symptoms do seem to be improving (coughing and fever and my last panic was on 9/23/2021).
On 03/07 I saw my PCP because of the two incidents of being awoken with pain in my left rib cage and extreme shortness of breath. In addition, I had a lot of burping so I was thinking it was gastrointestinal discomfort. She ruled that out and thought I was having a pulmonary embolism and said to go to the ER. I went to the ER and I had a CT scan and it was determined that I had blood clots in both lungs. I had a Heparin drip for 24 hours and they kept me over night. They sent me home with Eliquis starter back 10 mg twice daily for a week, then 5 mgs twice daily for the rest of the 30 days. My PCP prescribed it for 90 days with a recommended follow up CT scan in 3 months. In the hospital, they did an ultrasound for my legs and there were no DVTs. They also did an echocardiogram and there was nothing there to indicate any connection. The cause of the blood clots is unknown. I did not have any lengthy plane rides, road trips, surgeries, etc. that could have caused this. As recommended by the hospital, I did have follow ups with my PCP, cardiologist and pulmonologist. I don't have the pain or shortness of breath anymore. I do have shortness of breath occasionally, but I did have shortness of breath on exertion prior to this event. I have no idea if this is in relation to the vaccine.
Information has been received from a pharmacist concerning a pt who was vaccinated with measles virus vaccine live (also reported as measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) MSD). It was reported that the pt was a low titer for measles. NO further information was available. Additional information has been requested.
UNABLE TO OPEN LEFT HAND FULLY; This spontaneous report received from a patient concerned a 51 year old male. 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, and batch number: 1808986 expiry: 04-JUL-2021) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-JUN-2021, the subject experienced unable to open left hand fully. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from unable to open left hand fully. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Fever onset within 2-3 hours of shot. Pain in deltoid muscle that night and continues. Saturday 6/21 rash (size of quarter) began then intensified by Sunday 6/22 - getting bigger surface area.
this morning g I awoke with swelling; pain in my armpit of the injection arm; This spontaneous case was reported by a pharmacist and describes the occurrence of SWELLING (this morning g I awoke with swelling) and AXILLARY PAIN (pain in my armpit of the injection arm) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Dec-2021, the patient experienced SWELLING (this morning g I awoke with swelling) and AXILLARY PAIN (pain in my armpit of the injection arm). At the time of the report, SWELLING (this morning g I awoke with swelling) and AXILLARY PAIN (pain in my armpit of the injection arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment medication were reported.
1st dose pfizer vaccine was given to patient on 07/08/2021. We found out on 07/09/2021 vaccine was stored outside the recommended 31 day expiration window. We reached out to pt on 07/10/21 to get the 1st dose again. Patient will return to the pharmacy to repeat dose on 07/12/21.
Pharmacist administered vaccine, Patient started to have difficulty breathing and was turning red, pharmacist administered Epipen. Pharmacy called 911, Ambulance/EMTs took her to the ER.
Fever 101, chills, body aches, headache, restlessness. Lasted for about 24 hours and went away on its own
Moderate difficulty swallowing reported at Health unit at  1:50pm. Contacted Dr, VS 97.6, BP 114/70, apical pulse 96, respiration 20. Benadryl capsule given PO, DR prescribing Medrol pack.
Gave a 5 month old patient a dose of Kinrix; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 5-month-old male patient who received DTPa-IPV (Kinrix) (batch number 7P5J5, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th June 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 7th June 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: A 5 month old patient received a dose of Kinrix, which led to inappropriate age at vaccine administration. The reporter agreed to follow-up preferably by email.
8Jun Rt hip "arthritic type" pain, 9Jun rash started /c facial & oral cavity x2 days, 23Jun approx 2 wks later- seemed bout of rash to body that lasted x 3 days
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 13-Jul-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-364634 (Patient Link).
became red (site of inj) later same PM; next day more severe-red, swollen, & hot; tx DPH & Ice
Cellulitis - An acute, infectious inflammation of the skin - Warmth - differs from an injection site reaction - pain, tenderness to touch, redness, swelling.
Made them feel weird or hurt; Made them feel weird or hurt; This is a spontaneous report received from a contactable consumer (patient) communicated to a Pfizer sales representative. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown)  via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was not known if the patient was pregnant at time of vaccination. It was not known if the patient received other vaccines within 4 weeks prior to the COVID vaccine. It was not known if the patient was diagnosed with COVID-19 prior to vaccination. The patient experienced feel weird or hurt on an unspecified date. It was unknown if the patient received treatment in response to the event. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Pt recvd vax  on 27AUG92 & approx 1 to 2 wks following vax exp stiffness in jaw, pain & stiffness in inject arm;
sore arm; sleepy; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 52-Year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration, administered in right arm, on an unspecified date in Feb2021 at 5:00pm (at the age of 52 years old) as a single dose, for COVID-19 immunization. Medical history included diabetes. The patient did not have any known allergies. The patient did not experience COVID-19 prior to vaccination nor was tested for COVID-19 post vaccination. The patient did not take any concomitant medications in the past two weeks. The patient did not receive any other vaccines within four weeks prior to vaccination. The patient experienced sore arm and sleepy on an unspecified date. The patient did not receive treatment for the events. The clinical outcome of the events sore arm and sleepy were recovered on an unspecified date.  The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 mRNA VACCINE, were not provided and will be requested during follow up.
She started spotting and having periods way earlier than she normally does; Difficulty picking that foot up on that side; Not really feeling herself; She started spotting and having periods way earlier than she normally does.; Left side pelvic pain; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via unspecified route on 29Mar2021 at single dose for covid-19 immunization. Medical history was not reported. The patient's concomitant medications were not reported. On 29Mar2021 and exactly a week, 7 days after first dose, 05Apr2021, she started to have left side pelvic pain. The pain had consistently been there. She started spotting and having periods way earlier than she normally does. This was concerning to her. She had since then started experiencing a little difficulty picking that foot up on that side, referring to her left side; and she was not really feeling herself. Her second dose was this upcoming Monday on 19Apr2021. This report is not related to a study or program. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a registered nurse regarding a patient of unknown age and gender. Patient's medical history or concurrent conditions were not reported. On an unknown date, the patient received improperly stored GARDASIL lot # K010574, expiration date 08-APR-2017 (dose, strength and route were unknown). It was also received an inappropriate stored dose of VAQTA lot # L008665, expiration date 10-FEB-2017 (dose, strength and route were unknown). There was no concomitant therapies reported. At the time of the report, no adverse effects were reported. Additional information has been requested. This is one of several reports received from the same reporter.
Swollen at injection site and traveled down the arm towards in side of the arm. The swelling was not warm to the touch and was about 6 inches in diameter. It had a little redness around the area.
pt recv vax 29OCT97 & devel fever of 100.8 on 1NOV97 & Sunday & Monday 103.5;body aches on Saturday & Sun then chills, fever, h/a, cough;saw MD 3NOV97;CXR neg;urine negative;BP OR blood fine x/for elevated blood count;bacterial infect;weak
I felt fatigue and weak. The next morning went I woke up my throat hurt. My wife made me take a COVID-19 test when I got a 102 fever, and it was positive. The next day I felt like crap, I had a cough and the other symptoms as well. I ended up getting a sinus infection. Six days later I tested negative. I still have a cough. The fever lasted for 2-3 days. I talked to my doctor and he gave me a cough syrup but I never took it.
No other AE reported; PROQUAD was improperly stored and administered to a patient; This spontaneous report as received from a customer and refers to patient of an unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported.   On 16-NOV-2020, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) albumin status RHA, lot # T023917 was confirmed to be valid, expiration date 01-JUL-2021 (however lot # was also reported as S023917, confilciting infomartion) (dose, route of administration, vaccination site were not specified) for prophylaxis. The administered dose underwent a temperature excursion of - 5.1 degrees Celsius for 63 hours and 15 minutes. There were no previous temperature excursions. Digital data logger was involved. No additional adverse effect was reported.
Information has been received from a registered nurse concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or other concomitant medication. On 26-MAY-2017, the patient received an improperly stored dose of VARIVAX, in left thigh subcutaneously, lot # M046005, expiration date 18-NOV-2018. The sterile diluent used to reconstitute the VARIVAX was properly stored.  No adverse effect reported. Temperature was reported as: 15°F to 46°F (22.1°F) Time frame: 50 minutes Previous temperature excursion: No Data logger involved: Yes No further information was provided. Additional information has been requested.
Patient described onset of fever, body aches approx. 12 hours after vaccination.  Symptoms were not resolving after a week so she came for a f/u visit and bloodwork was done.  Bloodwork showed elevated liver enzymes, further bloodwork showed increasingly high liver enzymes and patient was complaining of generalized itching.
fell last night; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and FALL (fell last night) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced DIZZINESS (Dizziness). On 30-Mar-2021, the patient experienced FALL (fell last night). At the time of the report, DIZZINESS (Dizziness) and FALL (fell last night) outcome was unknown.            Concomitant medications were not provided. Treatment information was not reported.
Expired Boostrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 37-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 33A27, expiry date 7th November 2022) for prophylaxis.   On 9th February 2023, the patient received Boostrix. On 9th February 2023, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 09-FEB-2023 Reporter's Comment: The reporter was a pharmacist. The reporter reported that the patient received expired dose of Boostrix  vaccine. The reporter did consent to follow up via email. Additional supportive information: The patient received a Boostrix which was already expired, which led to expired vaccine used.
Fever - Temperature of 99.8F; Body Aches; Headache; Fatigue; Diarrhea; Chills; Arm Pain; A spontaneous report was received from a consumer concerning a 71-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events chills, arm pain, body aches, fever - temperature of 99.8f, headache, diarrhea, fatigue.  The patient's medical history included aspergillosis. Concomitant medications reported were antihistamines for aspergillosis.  On 22 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 032L20A) Intramuscularly in her left arm for prophylaxis of COVID-19 infection.  On 23 Jan 2021, the patient experienced the events chills and  arm pain. On 30 Jan 2021, the patient experienced body aches, fever, headache, diarrhea, fatigue. On the same day the lab test performed included body temperature: 99.9 F(high). On an unknown date covid test was conducted thrice which was negative.Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was unknown.  On 25 Jan 2021 the outcome of events chills, arm pain were resolved.The outcome of events body aches, fever - temperature of 99, 8f, headache, diarrhea and  fatigue were unknown.
Adverse reaction to vaccine: Pt received his first dose of the COVID-19 vaccine on 3/18/21. He stayed in the pharmacy for 15 minutes before walking out to his car, where he began to experience visual loss. He describes how "everything turned white and I couldn't see anything". He laid his seat back and symptoms resolved within 5 minutes. Pt checked his blood pressure when he got home and says it was 120/70. That was kind of low for him. Sounds like a vaso-vagal episode. Of note, he had not eaten yet that day.
At immediate time of 1st COVID vaccine , heart rate increased , sweaty , dizzy, tightening  of throat , sharp hear pain , red face . Lasted 3 hours . Continued on and off over 6 weeks .
Pt's father called pharmacy to report pt had a "softball sized lump" that was "red and warm" and "getting bigger."
Initial information received on 24-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves 18 years old male patient who received 0.5 mL dose of vaccines MENACTRA lot U6142AA, expiry date: 17-FEB-2020 via intramuscular route in the left deltoid on 21-Sep-2018. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to Wrong vaccine administered. It was reported that a patient received MENACTRA instead of MenB vaccine. It was unknown whether patient experienced any adverse reaction after the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
very light headed and having to hold on to my walker; my 2 booster shots from Moderna./they gave me a Pfizer of the booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Dec2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (I have received my COVID, my 2 booster shots from Moderna), for COVID-19 immunization; Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 20Dec2022, outcome "unknown", described as "my 2 booster shots from Moderna./they gave me a Pfizer of the booster"; DIZZINESS (non-serious), outcome "unknown", described as "very light headed and having to hold on to my walker".  Additional information: Consumer stated, "I am a senior and I received, I have received my COVID, my 2 booster shots (Hence suspect captured as COVID Booster shot) from Moderna. But I went for the third booster to my local and they gave me a Pfizer of the booster (Further not clarified, hence suspect captured as Unspecified Booster Shot) And now I am hearing on that they have a record of strokes from people receiving this Pfizer booster (general statement) which was exactly what I received and since then I have received it, I received it on 20Dec2022. I have found myself very light headed and having to hold on to my walker and I am very concerned about the side effects. And I want to know I have already told my family if anything happens that they should hold Pfizer responsible but I also want to ask if there is anything that Pfizer to do to dilute the power of this booster to help to prevent stroke?" Consumer was informed about the Role of Pfizer Drug Safety and suggested to contact Pfizer Medical Information Department for the concern. Consumer stated, "Well, this was a national news channel saying they are and I don't think that they could be saying this shady because that they could be sued for (statement incomplete). And I have another concern, that they know because I asked, I called my pharmacy at and asked them to stop the injection, the booster injection the people that are 65 and older and they said they have no control over that."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Next day pat had knot on injection site (R) thigh where PREVNAR vaccine was admin. Mom stated was red and swollen.