chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt was given ActHIB vaccine. It was drawn up with sterile water diluent instead of the diluent provided (NaCl). Vaccine given 2/18/08. No signs/symptoms reported. (Med error)
Passed out once over the weekend (2/20/2021-2/21/2021). Feels like she has a racing heart - started over the weekend and has persisted. I gave the pt instructions to see her PCP for evaluation. Pt stated she did have N/V, headache, low grade fever, body aches, and chills over the weekend as well but those symptoms have gone away.
Information has been received from a physician via a field representative. The reporter totally reported 4 patients of unknown age and gender: 2 were teenagers, 1 baby and 1 child whose age could not be determined but was described as immunocompromised. It was reported that one of the 4 patients received 2 dose of VARIVAX (Merck). The immunocompromised patient had only one dose of VARIVAX (Merck). The dose for the other 2 patients was unspecified. It was reported that 3 out of the 4 patients each developed shingles, including the immunocompromised child; the fourth patient developed unspecified reaction to the vaccine (it was unspecified what specific symptoms or reaction the patient developed, however the patient did developed). The physician did not define how long past the VARIVAX (Merck) the adverse events happened. One of the adverse events happened in December 2015 and another in February 2016. The time of the other 2 adverse events was unspecified. This report referred to the unspecified patient who developed unspecified reaction to the vaccine. This is one of several cases reported from the same reporter. Additional information has been requested.
Flu like symptoms of extreme chills and entire body shivering, muscle and joint pain, leg pain, fatigue, .  Lasted for two days
Vaccinee rec'd series of 3 Engerix-B injects (deltoid) according to 0, 1, 6 months schedule; About one month following the third dose, results of testing for Hepatitis B surface Antibody indicated she had a low titer;
enlarged left axillary lymph nodes.  Edema of the left axillary tail region.  left axillary adenopathy and edema of the left axillary tail. with extreme pain
Cold chills and Enlarged prostate, had trouble peeing. 4:30 till about 9:00 pm on 02/07/21.
Sore injection site, swollen arm, headache on 2nd day.  Relieved on 3rd day.  Severe itching and large welt at site on 5th day.
Immediately following vaccination, patient described dizziness and "hot flash" and moved from chair to floor. Patient treated with ice pack and monitoring of vitals for additional time. Symptoms completely resolved and patient released from clinic at 7:00pm.
This spontaneous report was received from a physician via a company representative, and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 02-MAY-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 "10 PK SD-PFS LLok w Tip", 0.5 ml, lot # L007720 with expiration date of 0-JUL-2016 (strength, route of administration were not reported). No concomitant medications were reported. No adverse effects and no product quality complaints were involved. On an unknown date, the vaccine was stored at a refrigerator and the longest reported temperature excursion lasted 192 hours, with a lowest recorded temperature of 1 F (also reported as 1 Celsius degree). There were also another excursions on unknown dates which lasted 100, 96, 24 and 24 hours with lowest recorded temperatures of 34 F (reported as 1.111111111 Celsius degrees), -1 F (also reported as -1 Celsius degree), 32 F ( reported as 0 Celsius degrees) and 0 F (also reported as 0 Celsius degrees), respectively. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "refrigerator (R)". This is one of several cases received from the same reporter. Additional information has been requested.
Have existing ear ringing  (Meniere?s Disease), but 10 minutes after the shot, the ear ringing elevated significantly to the point where walking distance and driving more than an hour is no longer possible.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiry not reported). On an unknown date, the patient developed shingles a few years later after receiving ZOSTAVAX. The outcome of shingles was unknown. Additional information is not expected.
Fatigue - resolved within 24 hours Tinnitus in both ears - never resolved/no abatement
a little achy/a little sore; She took paracetamol (TYLENOL) last night for the nerve pain because she couldn't sleep; This is a spontaneous report from a Pfizer Sponsored program, received by a contactable consumer (patient).  This 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number not provided), via an unknown route, on 26Feb2021 at single dose for COVID-19 immunisation. Second dose is scheduled due on 18Mar2021. Relevant medical history included neck surgery, heart disorder, arthritis, nerve pain, and cedar tree allergy.  Relevant concomitant medications included gabapentin for nerve pain, paracetamol (TYLENOL) for arthritis, heart medicines, oxymetazoline hydrochloride (MUCINEX SINUS) as antihistamine for cedar tree allergy. After first shot, she felt "a little achy" (but said that she usually does feels this way from her arthritis anyway; unsure if this is from the vaccine) and "a little sore". She took paracetamol (TYLENOL) last night for the nerve pain because she couldn't sleep. She is now taking guaifenesin (MUCINEX) sinus, an antihistamine. The patient is asking if she can take Gabapentin for her nerve pain on the left side of her neck to the arm. She had neck surgery several years back and she was prescribed with gabapentin for nerve pains. The stated "I was told about TYLENOL which I take for arthritis but didn't take it purposely had it without. I also take antihistamines for cedar tree. Last night I only took TYLENOL. I didn't want to compromise the vaccine''. The outcome of the events was unknown.  No follow-up attempts are possible. Information on Lot/batch number cannot be obtained.
Patient came in with her left arm swollen, red, and bruised. Patient states reaction started day after having gotten her flu shot. Left arm is red and hot to the touch.
Experienced Guillain Barre 2 weeks post injection,  went away on its own after approx. 1 month. Am suffering from SIRVA since 10/22/21 and have visited orthopedist / assigned PT but am nervous about the current pain being adversely affected by Physical therapy.
Began vomiting sat. am. and has had intermittent stomach cramping, some loose stools.  No fever noted.  No appettite, no energy.  Has kept down toast today, no vomiting since 7am
vaccine from the batch effected by temperature excursion; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine from the batch effected by temperature excursion) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     Concomitant products included ALLOPURINOL for an unknown indication.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine from the batch effected by temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine from the batch effected by temperature excursion) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medicines were not included  Concomitant medicine include Allopurinol  Action taken with mRNA-1273 in response to the event was unknown   This case was linked to US-MODERNATX, INC.-MOD-2021-085726 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-085726:Husband case
Dry eyes; 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 DRY EYE (Dry eyes) 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 DRY EYE (Dry eyes). At the time of the report, DRY EYE (Dry eyes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient developed rash to left chest. Left shoulder, and upper left arm. BENADRYL 25mg PO was given.
pt reported swelling, soreness, redness @ site;pt exp fever, diaphoretic & felt sick;pt recv vax while away;
child well until 1130PM 9/28/99;URI, cough, given neb;awoke well @ 230AM;found dead @ 530AM;autopsy done;lymphadenopathy;slides pending ;dx viremia on preliminary report;
This spontaneous report as received from a physician refers to a 26 year old female patient who no drug allergies. The patient's pertinent medical history was none. On 29-MAY-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # K003074, expiry date: 13-MAR-2015) intramuscularly. Concomitant medications were none. On 29-MAY-2014, the patient also received MMR II and ADACEL. On 30-MAY-2014 the patient developed fever of 38.6 degree Celsius (C) and pain in the left deltoid area. The patient took TYLENOL and ADVIL which helped the fever of 100.8 Fahrenheit (F). Her left deltoid was swollen and indurated but not red. She received IV fluids. BENADRYL and TYLENOL (manufacturers unspecified), and was sent home. On 02-JUN-2014, she still had a fever and her left deltoid was still painful. The patient then received an ultrasound of the left deltoid area. Edema was found in the left deltoid muscle. The patient also had "2 ill define, erythematous, blotchy areas on the skin slightly inferomedial to the left deltoid muscle. The left deltoid was found to be enlarged compared to the right deltoid muscle. There was no abscess in the left deltoid area." The patient was given cephalexin (manufacturer unknown) and hydrocodone (manufacturer unknown). The outcome of the events was unknown (reported as unspecified). The causality was not reported. Additional information has been requested.
felt a popping or burst at the injection site / popping sound heard; pain, at the injection site, when he went to use his left arm/pain on his left arm; pain / has awakened him; pain on his left arm is evident when he moves to reach back for his seat belt / to put on his coat; injection site may have been a little low on his arm; This case was reported by a consumer via call center representative and described the occurrence of injection site discomfort in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of no adverse event (1st dose received on 13th August 2020).   On 5th December 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 5th December 2020, unknown after receiving Shingrix, the patient experienced vaccine administered at inappropriate site. On 7th December 2020, the patient experienced injection site discomfort, pain in arm, poor sleep and activities of daily living impaired. On an unknown date, the outcome of the injection site discomfort, pain in arm, poor sleep, activities of daily living impaired and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the injection site discomfort, pain in arm, poor sleep and activities of daily living impaired to be related to Shingrix.  Additional details were reported as follows: The patient felt a popping or burst at the injection site when he moved his left arm behind his head. The patient did not thinking too much of the popping sound heard, but began to have consistent pain, at the injection site, when he went to use his left arm. The patient reported that pain on his left arm was evident when he moves to reach back for his seat belt, when he moves to put on his coat, it had awakened him in the middle of the night when he turns over in bed on the left side. The patient reported that when he experiences pain, he rubs the area of the injection site on the left arm that helps to dissipate the pain. The patient went to see his Health Care Professional and the only thing his HCP told him was the Shingrix injection site might have been a little low on his arm, which led to vaccine administered at inappropriate site. No medication was prescribed for pain. The patient did not take Tylenol or Ibuprofen for the pain. The patient would like to talk to someone from safety team, to see if others have experienced this type of adverse event. The patient did not given permission to his contact Health Care Professional. The reporter did not consented to follow up.
First 24 hours - abdominal pain, nausea, chills, itching. Then swollen lips, face & throat. Immediately after injection felt flushed arm hurt immediately.
Redness, warm, itching at injection site, slight swelling, cool compresses & BENADRYL.
t103 since 16AUG96 1 days p/vax;no redness or soreness @ inj site;2mm cold sore on corner of mouth;
Cough, full body aches, stabbing pain all over her body, frontal and occipital headache, loss of appetite.Persisted for 36 hours
Breakthrough Infection on al older woman after her two shots of Moderna; COVID-19; This spontaneous case was reported by a physician and describes the occurrence of INFECTION (Breakthrough Infection on al older woman after her two shots of Moderna) and COVID-19 (COVID-19) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFECTION (Breakthrough Infection on al older woman after her two shots of Moderna) and COVID-19 (COVID-19). At the time of the report, INFECTION (Breakthrough Infection on al older woman after her two shots of Moderna) outcome was unknown and COVID-19 (COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   HCP did not know her exact age, guessed patient was between 70 and 80 years old. Patient had two COVID vaccines more than 6 months ago but recently tested positive for COVID.  No concomitant medication was provided by the reporter.  No treatment information was provided by the reporter.  This is a spontaneous case concerning an elderly female patient with  concurrent medical condition of Immunocompromised, who experienced non serious, AESI, unexpected event of COVID-19. The event occurred unknown days after the second dose of mRNA-1273 vaccine. It was reported that patient had two COVID vaccines more than 6 months ago but recently tested positive for COVID. Re-challenge is not applicable. Concurrent medical condition of Immunocompromised remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 13-Nov-2021: Follow-up received on 13-Nov-2021.  Email Id was added and Address updated.; Sender's Comments: This is a spontaneous case concerning an elderly female patient with  concurrent medical condition of Immunocompromised, who experienced non serious, AESI, unexpected event of COVID-19. The event occurred unknown days after the second dose of mRNA-1273 vaccine. It was reported that patient had two COVID vaccines more than 6 months ago but recently tested positive for COVID. Rechallenge is not applicable. Concurrent medical condition of Immunocompromised remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Presion en el pecho, espalda, fuerte dolor de cabeza, nausea, dolor muscular, debilidad, cansansio, presion alta, fiebre
C/O left upper ext. paresthesia after 3rd Engerix B injection.
Child began running a fever of 104, same day of vaxs. Fever came down w/Motrin. The next am, fever climbed again to 104.2. It again came down w/Motrin. Md found no other sx/problems & told mom fever was rxn to the shots. Fever gone on 12/17
Patient discharged after 23 hours    60-year-old with past medical history significant for chronic obstructive pulmonary disease, diabetes 2, hypertension, hyperlipidemia admitted with acute hypoxic respiratory insufficiency secondary to COVID illness.  Patient is fully vaccinated for COVID.  She was noted to be hypoxic with ambulation the ER.  Also was noted to have elevated lactate in the ER as well.  Suspect patient's elevated lactate secondary to dehydration, hypotension from decreased oral intake with COVID illness.  Her blood pressure responded well to IV fluids, elevated lactate resolved.  On room air during hospital stay.  Patient discharged stable condition.  Home ACEI reduced by 1/2 at discharge and continued on Coreg and advised to follow up closely with PCP. Patient is a 60 y.o. female with a past medical history significant for chronic obstructive pulmonary disease, tobacco abuse, diabetes mellitus type 2, essential hypertension, hyperlipidemia and chronic low back pain who presents today with a chief complaint of generalized body aches.  She was found the be COVID-19 positive, hypoxic with ambulation, and hypotensive with a lactic acidosis.   Patient had 5 days of symptoms prior to presentation.  She has been vaccinated previously with 2 doses.   Patient was admitted for further evaluation and treatment.  She responded remarkably well to IV fluid resuscitation with resolution of her hypotension and lactic acidosis.  Her hypoxia also improved and the morning of 11/30 she was able to ambulate around her room without desaturation on room air.   Given patient's significant improvement, she was discharged home in stable condition on 11/30/2021.
he feel like he kind of weak; he had the side effect, because he is weak; This is a spontaneous report from a contactable consumer or other non hcp. This Patient's wife reported for a 71-year-old male patient (Husband). A 71-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported; Expiry Date: Unknown), via an unspecified route of administration, administered in Arm Right on 15Sep2021 at 13:30 (at the age of 71-years-old) as dose number unknown, single for covid-19 immunisation. Medical history included diabetes mellitus and high blood pressure. Concomitant medication included metformin; diazepam (BENZOPIN); glimepiride. The patient experienced he feel like he kind of weak; he had the side effect, because he is weak on 15Sep2021. When asked about lot number it was reported that she do not have the card. They did not give her this information, she reported when the patient got the shot on yesterday but she don't see any card or anything. The reporter informed about her name and her husband's name. She said her husband received the shot on yesterday and he is not, he feel like he kind of week like 'concenter' (Further not clarified) and she was just trying to see the status check, and if the patient have to go to hospital or what, he had kid (voice not clear).  He was around 169 (Pounds). She reported that she was just trying to find that how long would he had the side effect because he is weak. She was given contact details of Pfizer Medical Information Department. Outcome of the event was unknown.   The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.
Bloody noses/ Nose bleeds; Runny nose; headache; Little bit of Asthma; Her grandson is nervous about this; Pretty upset; This is a spontaneous report from a contactable consumer or other non hcp (the patient's grandmother). A 15-year-old male patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration on 13Jun2021 as single dose for covid-19 immunization. The patient previously received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration on an unknown date in May2021 as single dose for covid-19 immunization. The patient medical history was not reported. There were no concomitant medications. On 14Jun202, the patient had a headache and a runny nose and then the following day the patient had 4 bloody noses during the day and one at night. The patient is continuing to have bloody noses. On an unknown date in Jun2021, the reporter also stated that the patient might have a little bit of asthma. The reporter mentioned that the patient was pretty upset, nervous and he had the nose bleeds they are a lot, not just a little drip. The patient was treated with Advil for headache. The outcome of the events nose bleeds was reported as not recovered; runny nose was reported as recovering while other events were reported as unknown at the time of report.  Information on the lot/batch number has been requested.
This is a spontaneous report from a contactable consumer (patient). An 83-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: FF8841; Expiration Date: Unknown), via an unspecified route of administration in Arm Left on 29Sep2021 17:00 as dose 3 (booster), single for COVID-19 immunisation. The patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EN6201; Expiration Date: Unknown), via an unspecified route of administration on 22Feb2021 as dose 1, single also received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EN6203; Expiration Date: Unknown), via an unspecified route of administration on 15Mar2021 as dose 2, single for COVID-19 Immunization with no adverse events. The patient previously received Flu shot (Formulation: unknown dosage shot to her left arm, Lot Number: unknown; Expiration Date: unknown), on 19Aug2021, the patient was taking flu shot to stay safe. The patient medical history was not reported. Concomitant medications included OXYGEN taken for an unspecified indication, start and stop date were not reported. It was reported that the patient has been on oxygen for 15 years further it was mentioned that the patient was on it before Covid shot. It was reported that the patient stated that she is weak, chills, can't eat, had a hard time getting her to drink, has been in bed, left arm hurting/sore, and got booster yesterday on 29Sep2021. The patient underwent lab tests and procedures which included body temperature which is unknown on an unspecified date in Sep2021. The patient did not receive the treatment for all the events. The outcome of all the events was not recovered.   No follow-up attempts are possible, no further information is expected.
Pt describes waking up in the middle of the night with a fever of 102. Continued fever throughout the next day. Feeling of Malaise continuing through today. Sore arm. Erythema and swelling and heat detectable to the touch at and around the injection site from 2 inches above the injection and going down the arm to the elbow. The approximate width of the visible rash is 2 - 3 inches.