chrisvoncsefalvay/vaers-outcomes huggingface dataset:
could not sleep all night; felt like vomiting; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of insomnia in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced insomnia (Verbatim: could not sleep all night) and nausea (Verbatim: felt like vomiting). The outcome of the insomnia and nausea were not reported.   It was unknown if the reporter considered the insomnia and nausea to be related to Shingles vaccine.     It was unknown if the company considered the insomnia and nausea to be related to Shingles vaccine.   Additional Information: GSK receipt date: 31-MAR-2023 The case was received from the patient via interactive digital media. The patient reported that just had his or her second shot and it knocked him or her out.  The patient could not sleep all night because he or she felt like vomiting.  The patient said it was not fun but he or she guess it was better than getting Shingles. The follow-up could not be possible as no contact details were available.
This spontaneous report was received from a consumer regarding his approximately 22 year old daughter. The patient had seasonal type allergies. On an unknown date in June 1993, the patient was vaccinated with first dose of RECOMBIVAX HB (lot number 1513V and expiry date unknown) (dose, frequency and route were not reported). The patient was vaccinated with second dose of RECOMBIVAX HB in August 1993 (lot number: 0841W and expiry date: unknown) and finally the third dose on an unspecified date with unspecified lot and expiration date on an unknown date in 1993. The patient had completed the entire three doses of RECOMBIVAX HB in 1993. Concomitant therapies included ZYRTEC and other vaccinations (product name unspecified) that she got at the same time. On an unknown date (reported as last few years), the patient was diagnosed with a type of epilepsy. The reporter stated that his daughter's vaccination with RECOMBIVAX HB proved ineffective. On an unknown date in August 2015 (reported as recently, beginning of August) the patient had some blood work done to test for titers for hepatitis B and it revealed that the patient had no antibodies or immunity developed even after completing all the three doses of the vaccination. The patient sought medical attention and the current physician of his daughter was revaccinating her because she did not seroconvert to the original vaccination. He was concerned for his daughter as she was working in a hospital during college and he hoped she was not exposed to the hepatitis B virus while working there. The outcome of the events was reported as recovering/resolving. Upon internal review, the epilepsy was considered as other medically significant event. Additional information has been requested.
Patient received vaccine on 9/24, went to ER on 9/25 with shortness of breath, lip, and facial swelling.
No adverse event reported.  This was a vaccination error.  The medical assistant assigned to this patient gave the vaccine which expired on 9/21/2021 to the patient.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Gastroesophageal reflux and Osteopenia.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 07-Jan-2021, PAIN IN EXTREMITY (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included muscle relaxant, medicine for reflux and osteopenia.   This case was linked to MOD-2021-019461 (Patient Link).
Episodes of stiffening, turning red about 10 seconds. Then acted dazed. 3 episodes day of vaccine several next day. About 25 in all. Seen by neurologist 9/30 and admitted. Video EEG NL; no further episodes after admission.  Discharge Summary received on 12/07/2004 states final diagnosis paroxsymal event suspicious for seizures.
- 10:30 AM rcvd H1N1 shot, 12/4/09 - 2 AM to ED with stridor, wheezing. Resolved with Alb neb & PREDISOLONE normal CXR.
Pain within 30 min, became red and hard within a few hours of administration. Clinical observation by RN: arm is red, warm to touch, redness and swelling extend from upper arm over elbow onto forearm.
severe diarrhea; achy/chills that night; achy/chills that night; fatigued and severe headache for two days (had to miss work); fatigued and severe headache for two days (had to miss work); fatigued and severe headache for two days (had to miss work); not sleep on the third night; dehydrated; gritting of teeth to the point of having a headache; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and Expiration Date was not reported) via an unspecified route of administration in left arm on 10Apr2021 14:45 as dose 1, single for COVID-19 immunization (at the age of 52-year-old, non-pregnant). Medical history included PMDD, allergies from cipro, tequin, seasonal and other allergies like ingredients in makeup, patient had COVID-19 prior vaccination. Patient received unspecified concomitant medications in two weeks. Patient had not tested covid post vaccination. The patient experienced severe diarrhea a few hours after vaccine, achy/chills that night, fatigued and severe headache for two days (had to miss work), felt like dehydrated on third day even though constantly drinking water/gatorade, gritting of teeth to the point of having a headache and not sleep on the third night on 10Apr2021 20:00. Patient did not receive any treatment for the events. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Body aches, chills, mild headache, fatigue, lowered blood pressure - normal is around 99/65 and BP lowered to 79/50 and current is 85/59 approximately 48 hours after second injection.
Pt called with c/o redness, pain & swelling in (R) arm. Flu like symptoms of fever > 101.0 fatigue, muscle aches, red & swollen (R) deltoid 5x4 inches with mass or hard lump. Nausea chills body aches.
Red rash to chest, under arms, it back, it face, raised temp of 101. Seen by physician on 030504.
RESTORED TO CIRCULATION PATTERNS AND  COMFORTABLE NERVE RESPONSES IN BACK AND LEGS ALONG WITH A GENERALLY GOOD FEELING OF NORMAL SELF FROM WHAT SEEMS LIKE YEARS AGO; This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. The patient's past medical history included sciatica, and general pain in spine. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced restored to circulation patterns and comfortable nerve responses in back and legs along with a generally good feeling of normal self from what seems like years ago. The action taken with covid-19 vaccine was not applicable. The outcome of restored to circulation patterns and comfortable nerve responses in back and legs along with a generally good feeling of normal self from what seems like years ago was not reported. This report was non-serious.
dizziness; This is a spontaneous report from a contactable consumer. An 86-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: EL9261) via an unspecified route of administration in left arm on 09Feb2021 at 11:45 as single dose for COVID-19 immunization. Medical history included 1 kidney removed and known allergies to Penicillin, Cephalosporins and Hazelnuts. Concomitant medication(s) included losartan, amlodipine, atorvastatin calcium and aspirin. Patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient was not diagnosed with COVID-19. On 11Feb2021 at 10:00, patient started having dizziness 48 hours after vaccine. Patient did not receive the treatment for events. The outcome of the events was recovered on an unspecified date of Feb2021.
Swelling under left arm in lymph node area along with some pain in the same area. The swelling subsided after a few days.
negative [antibody test]; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 ANTIBODY TEST NEGATIVE (negative [antibody test]) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced SARS-COV-2 ANTIBODY TEST NEGATIVE (negative [antibody test]). At the time of the report, SARS-COV-2 ANTIBODY TEST NEGATIVE (negative [antibody test]) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, SARS-CoV-2 antibody test: negative negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were given No treatment information was provided   This case was linked to MOD-2021-058244 (E2B Linked Report).; Sender's Comments:  MOD-2021-058244:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 10Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 28 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 15Nov2021 as dose 3 (booster), single (Lot number: 939903), in left arm for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing). Concomitant medication(s) included: CONCERTA oral; PROPRANOLOL oral; MIRENA. The patient had no known allergies.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result. Therapeutic measures were taken as a result of vaccination failure, covid-19. It was reported the treatment was received with Paxlovid, oral route of administration, treatment start date was given as 28Apr2022 and stop date was given as 28Apr2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
After I received my second vaccine I started my period and had extreme clotting. I just got off my period 2 weeks before and NEVER have 2 periods in the same month. It was extremely pain full, extremely heavy, and extreme clotting.
got breakthrough COVID-19; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (got breakthrough COVID-19) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (got breakthrough COVID-19). At the time of the report, COVID-19 (got breakthrough COVID-19) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.Concomitant medication of the patient was not reported. No treatment information was provided by the reporter.; Sender's Comments: This case concerns patient of unknown age and gender with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19. The event occurred at an unknown day after a dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
4.5cmx4.5cm erythema around injection site on right deltoind. Left warm to touch; mild swelling Td site. Treated with Benadryl 25mg PO Q 4-6 hours, cold compresses. Keflex 250/5 2tsp PO if redness worsens.
I really don't know time of injection, ask patient.  Severe headache, body aches, fever 102, red and tender L deltoid 12 x 7 cm size, sore throat.  Rapid strep neg.  Swollen tender glands in sup cervical areas.
went urgent care, for  calluses on his foot; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPERKERATOSIS (went urgent care, for  calluses on his foot) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033h21a) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.    On 10-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2022, the patient experienced HYPERKERATOSIS (went urgent care, for  calluses on his foot). At the time of the report, HYPERKERATOSIS (went urgent care, for  calluses on his foot) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The height of the patient was 5feet 4 inches.  The patient had no allergies to medications, food and other products.  The patient had not tested positive for COVID-19 or diagnosed with it.  The patient did not receive any vaccine 1 month prior to Moderna COVID-19 vaccine.  The patient had not experienced a similar event in the past.  No treatment medications were reported.   This case was linked to MOD-2022-491831 (Patient Link).
Soreness to injection site; Headache, mild; This is a spontaneous report from a contactable nurse, the patient. A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via unspecified route of administration, on 07Jan2021 at 17:00 PM (at the age of 37-year-old) as a single dose for COVID-19 immunization. Medical history included asthma, and polycystic ovaries. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included cetirizine hydrochloride (ZYRTEC), ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS), ubidecarenone (COQ10). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not have any allergies to medications, food, or other products. On 07Jan2021 at 21:00 PM, the patient experienced headache, mild. It started 4-5 hours after, continued to next day. The next day, 08Jan2021 the patient experienced soreness to injection site. The events were reported as non-serious. The patient did not receive any treatment for the headache, mild and soreness to injection site. The clinical outcome of the events headache, mild and soreness to injection site was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   Information on the Lot/Batch number has been requested
Chills (over 12 hours), Nausea, Fever, muscle aches, headache
The first day I felt achy on the side of the injection, Next day it was swelling and it hurt under armpit for about 4 days, 2 days later I woke up with Nausea and abdominal pain, Headaches that came and go, Lost my balance and low grade fever, Weakness, body ache and pain, short of breath.
606 doses were given after expiration date; Vaccine expired on 13-OCT-2021 and placed in refrigerator on 29-OCT-2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-OCT-2021 and placed in refrigerator on 29-OCT-2021) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-OCT-2021 and placed in refrigerator on 29-OCT-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-OCT-2021 and placed in refrigerator on 29-OCT-2021) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported.
Headache, Myalgia, Arthralgia, Fever, fatigue, pain and redness at site Narrative:
approx 45mins following vax pt presented to school w/ c/o itchy rash @ inj site,then neck,ankles,etc;the rash migrated;pt denied dyspnea;was taken to MD as precaution-given Claritan orally
Severe body aches, temp reaching 102.8 for 24 hours regardless of alternating tyl and ibu.. next day was 101 temp and by Thursday I was afebrile except severe sharp pain up through my head. By Friday it was like nothing ever happened
COVID/She does believe that she got COVID; COVID/She does believe that she got COVID; foggy head/Feels like she has 2 heads, 1 inside of the other; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "recovered" and all described as "COVID/She does believe that she got COVID"; FEELING ABNORMAL (non-serious), outcome "not recovered", described as "foggy head/Feels like she has 2 heads, 1 inside of the other". The patient reported foggy head after getting the booster shot and wanted to know any suggestions on what to do for this fogginess. She reported that she had COVID past year, and now she's ok. The patient reported that a friend of hers got COVID-19 and received Paxlovid. On the paper it mentioned that one of the possible side effects was 'foggy head' (sic)". She had the booster and she's been having that for quite some time. She asked the doctors, and they didn't know what she was talking about. It comes and goes, so it's not there all the time. The patient reported that she received the Pfizer COVID-19 Vaccine Booster and ever since she got it, she has had some foggy head. She has been having it for quite some time; it comes and goes, it's not there all the time. She clarified she was  not sure when the onset of the foggy head was. She does believe that she got COVID, but if so, it was long time ago. This foggy head she still has from time to time but lately it has occurred a little bit more often than ever. When she saw the side effects that were listed in some of the drug which has to do with COVID there was one called foggy head; so she thought that would fit the way to describe her head. Before then she couldn't think of how to describe her head and no one paid any attention anyway. It occurred to her that maybe if she called Pfizer someone could tell her what do you mean by 'foggy head' and if there anything to suggest that can do for it. She guessed Pfizer either didn't know or did not want to say without more information yet when caller queried if these inquiries were addressed with agent. She feels like she has 2 heads, 1 inside of the other.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Received shot at 11:35 am Friday 1/8/21. Woke up 1/9/21 with chest pain, in SVT HR 140s-180s, persisting for 8+ hours until treated by cardiologist with addition of Flecainide.  Flecainide 50 mg twice daily now part of medications.
Infant found unresponsive laying on stomach am of 6/3. The autopsy states suffocation.
Patient on chemotherapy for ALL.  Administered 4th IPV.  Given outside recommendations.
Both of her big toes went numb; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Both of her big toes went numb) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced HYPOAESTHESIA (Both of her big toes went numb). At the time of the report, HYPOAESTHESIA (Both of her big toes went numb) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment details included Anti-inflammatories
Sore arm, red, swollen, itchy, red blotch on skin from injection towards elbow - 3" by 6" - began 4 hours after injection and lasted 5 days Low grade fever (99.4), full body aches, chills, lethargic -began 8 hours after injection and lasted 48 hours
Very dizzy after the second injection and now she can not walk. Symptoms of Guillain Barre Syndrome.
Expiration date doesn't match expiration date given under moderna lot number look up on the moderna website.
Malaise, sinus congestion, dizziness, mild fever (99.4 degrees F), increasing in severity since waking at 5:45 am April 15  Sore left arm, including some tingling along left forearm and back of left hand (diminished within a few minutes of waking)
DVT RLE, Xarelto 15mg PO BID x 3 weeks, resolved
Thyroid swelling Difficulty breathing--one week post vaccination Sore throat abdominal pain Swelling of face Constipation All started one week after vaccination