chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 10:33 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 10:33 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 73.73 for dose administered on 07-JAN-2021.  No concomitant medications were reported.  Batch number 025L20A underwent temperature excursion on 07-JAN-2021 with temperature 34 degrees Fahrenheit at 09:00 AM to 10.00 AM. This vial was moved to fridge on 05-JAN-2021 and beyond use date for the vial was reported as 27-JAN-2021. Product moved to clinic on 07-JAN-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (E2B Linked Report).; Sender's Comments:  MOD-2022-566976
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 06-FEB-2017, the patient received an expired dose of PNEUMOVAX 23 Lot # L024129 with expiration date: 21-JAN-2017 (dose and route of administration were not reported) for prophylaxis. No adverse effect was reported. There was no product quality complaint involved. Additional information has been requested.
sore arm; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (Solution injection; Batch/Lot Number: EN6201), via an unspecified route of administration on 18Feb2021 single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced a sore arm but nothing else. Patient reported that several people had asked if this could have been a reaction to the vaccine. The outcome of the event unknown.   No follow-up attempts are needed. No further information is expected.
Received Tdap at approximately 9:30am.  Dizzy, overwhelmed and "out of balance" feeling for most of day after injection.  Crying unprovoked.  Awoke approximately 1:30am with shaking, chills and tightness in chest, crying uncontrollably, swollen and white tongue. Temp 99.7 orally at that time. Took antihistamine.  Continued to feel dizzy, off balance throughout next day.  Temp 99.0 oral next day.  Pain and redness at injection site.  Tongue continued to feel swollen and used antihistamines. Day 3 temp normal, still dizzy, agitated. Tongue remained slightly swollen, continued with antihistamine, pain at injection site.  Day 4 continued with dizziness and fatigue with complaints of "body buzzing".  Day 5 same symptoms continue.  Evaluated by physician on day 4 and 5.
loss of smell; my nose is also stuffy; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (loss of smell) and NASAL CONGESTION (my nose is also stuffy) 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 ANOSMIA (loss of smell) and NASAL CONGESTION (my nose is also stuffy). At the time of the report, ANOSMIA (loss of smell) and NASAL CONGESTION (my nose is also stuffy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported by the reporter Treatment information was not reported.    Reporter did not allow further contact
My left elbow and shoulder blade felt sore/stiff.  The shoulder blade got better but the left elbow still bothers me.  Nothing terrible and not all he time.  Feels kind of like a stiff neck but in the elbow.
Pt began having throat tightness, shortness of breath and chest tightness and palpitations with lightheadness and weakness
pain in bilateral eyes; left hand and left leg numbness; tongue numbness with fasciculation to the left side; tongue numbness with fasciculation to the left side; headache; nausea; This is a spontaneous report from a contactable consumer (parent). A 13-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number ew0186, expiration date was not reported) via an unspecified route of administration at the right arm on 16Jun2021 (at the age of 13-years-old) at single dose for covid-19 immunisation. Medical history included ADD (attention deficit hyperactivity disorder) from an unknown date. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant. The patient was not pregnant at time of vaccination. Concomitant medication included ibuprofen (ADVIL) and muscle relaxer taken for unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number ew0176,expiration date was not reported) via an unspecified route of administration on 27May2021 (at the age of 13-years-old) at single dose for covid-19 immunisation and no reaction on previous exposure to drug. The patient experienced pain in bilateral eyes, left leg numbness, left hand numbness, tongue numbness with fasciculation to the left side, headache, and nausea on 17Jun2021 17:30. No treatment was received for the events. The patient had not been tested for COVID-19 since the vaccination. The outcome of the events was recovered in Jun2021. The report was reported as non-serious.
trouble walking; had adverse effects from the first shingles vaccine; Initial information received from on 15-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer.  This case involves an unknown age and unknown gender patient who had trouble walking and had adverse effects from the first shingles vaccine while receiving vaccine Influenza Vaccine and shingle vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number; formulation; strength; expiry date: not reported) via unknown route in unknown administration site for immunization.  On an unknown date, the patient received an unknown dose of suspect shingle vaccine produced by unknown manufacturer (lot number; formulation; strength; expiry date: not reported) via unknown route in unknown administration site for immunization. Information on the batch number was requested.  On an unknown date the patient had trouble walking (gait disturbance) (unknown latency) following the administration of Influenza Vaccine and shingle vaccine. This event was leading to disability.  On an unknown date the patient had adverse effects from the first shingles vaccine (adverse event) (unknown latency) following the administration of Influenza Vaccine and shingle vaccine. It was reported that FDA (Food and Drug Administration) has finally recalled it after many years because there were so many sever adverse effects.  Action taken: Not applicable for both events with respect to both suspects.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the event trouble walking and for the event had adverse effects from the first shingles vaccine.; Sender's Comments: Sanofi Company comment dated 24-Jan-2022: This case involves an unknown age and unknown gender patient who had trouble walking while receiving vaccine Influenza Vaccine and shingle vaccine. The event was leading to disability. However, patient's medical condition at the time of vaccination and laboratory tests ruling out alternate etiologies were not reported. Further information regarding previous vaccination tolerance and laboratory investigations excluding alternative etiologies for the reported events are needed to fully assess this case. Based upon the reported information, the role of a vaccine cannot be assessed.
36 hours post 2nd COVID dose a red firm and tender  rash appeared two inches below the injection site. It is painful and warm to the touch and seems to be increasing in diameter as time goes by.
One week after taking the second dose of your Covid 19 vaccine my mind cleared up a great deal,My other symptoms have improved,the improvement in my brain is outstanding; This spontaneous case was reported by a patient and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (One week after taking the second dose of your Covid 19 vaccine my mind cleared up a great deal,My other symptoms have improved,the improvement in my brain is outstanding ) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Chronic fatigue (suffering with Chronic Fatigue for eighteen years), Cerebral disorder (fogged brain, searching for words and difficulty with simple math) and Short-term memory loss.    In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (One week after taking the second dose of your Covid 19 vaccine my mind cleared up a great deal,My other symptoms have improved,the improvement in my brain is outstanding ). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (One week after taking the second dose of your Covid 19 vaccine my mind cleared up a great deal,My other symptoms have improved,the improvement in my brain is outstanding ) outcome was unknown.            No information on concomitant medication was reported. The patient was suffering with a fogged brain, short term memory loss, searching for words and difficulty with simple math. One week after taking the second dose of COVID-19 vaccine the patient's mind cleared up a great deal. No information on treatment medications was reported.   This case was linked to MOD-2022-583933 (Patient Link).
Headache; Body aches; 1st dose on 2019, 2nd dose on 20Sep2022; This case was reported by a consumer via patient support programs and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of headache (received 1st dose in 2019 and also experienced body aches, refer case US2022AMR136388).   On 20th September 2022, the patient received the 2nd dose of Shingrix. On 20th September 2022, less than a day after receiving Shingrix, the patient experienced headache, general body pain and drug dose administration interval too long. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the headache, general body pain and drug dose administration interval too long were unknown.   The reporter considered the headache and general body pain to be possibly related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR136388   Additional Information: GSK Receipt Date: 21-SEP-2022 Reporter's Comments: The patient had headache and body aches. The reporter thought that the event might had been related to Shingrix. The reporter did not give consent to follow up. Additional Supportive Information: The patient received 2nd dose of Shingrix later than recommended time interval, which led to lengthening of vaccination schedule.; Sender's Comments:  US-GSK-US2022AMR136388:Same reporter/ 1st dose
ActHIB vaccine that had been reconstituted with sterile water rather than 0.4 % saline, no AE; Initial information and additional information received on 10-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a four months old male patient who received 0.5 ml second dose of vaccine HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ055AAA, Exp. Date 20-Apr-2022) via intramuscular route in the right vastus lateralis on 10-Sep-2019 that had been reconstituted with sterile water rather than 0.4 % saline.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR), ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) for Immunisation.  It was a case of actual medication error due to wrong solution used in drug reconstitution.  At the time of reporting, no adverse reactions were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.  List of documents held by sender: none.
Lightheaded ness 36 hours after.  Off balance when standing, or moving head
Developed raised red circular bumps all over body on 9/13/21. Went to doctor on 9/17/21. Skin condition accompanied by recent anemia caused doctor to be concerned with liver. Ran series of tests including blood tests. Blood tests resulted in finding blood and protein in urine. Referred to urologist who ran test for bladder cancer and kidney mri, turned up nothing. Advised to re-test urine in 6 months. When considering getting booster, decided to check for possible link. Became concerned on similarities.
patient reports sore throat and numb lip about 23 mins after vaccine.  Benadryl given at 3:03p, patient reports relief at 3:09p and symptoms completely resolved by 3:18p
within a month of second Pfizer COVID vax - I sustained a detached retina (fixed after 4 separate surgeries)  plus a PVD in the other eye. plus unexplained headaches 3-4 times a week requiring a Brain MRI and visiting a neurologist. Plus unexplained eye nose and throat dryness requiring eye drops.  Lastly - significant tinnitus in my left ear which is STILL unresolved today.  NONE of these conditions were present in my health before those two COVID shots - ever.
11/10/14 started itching-night. Fever (did not take). 11/11/14 joints hurt (toes, hands, feet, hips). 11/12/14 couldn't get out of bed. 11/13/14 OV to PCP given PHENERGAN 25mg IM. Rx BENADRYL 25mg every 6 hours prn, clindamycin 150mg TID. OV HD. Lt upper arm red 12cm x 9cm. Warm to touch.
Moderna Covid -19 Vaccine EUA,  My left arm  at the injection site has a 3 inch round area of redness,  warmth and swelling. The center has an indentation and is dark red.  Began the next morning and it has not changed. I developed pain in some of the joints in my hands, which  resolved yesterday. I felt nauseous this morning, but it has passed.
child experienced generalized macular papular rash over body with "strawberry toungue" beginning 06/03/09 afebrile
I get short of breath; Weak; Tired all the time; Orthostatic hypotension; My thinking is not like it should be; not able to think properly; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient received BNT162b2 (BNT162B2, Solution for injection), as dose 1, single (Lot number: EL3246) and as dose 2, single (Lot number: EL9263) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL taken for hypertension. The following information was reported: DYSPNOEA (non-serious), outcome "unknown", described as "I get short of breath"; ASTHENIA (non-serious), outcome "unknown", described as "Weak"; FATIGUE (non-serious), outcome "unknown", described as "Tired all the time"; ORTHOSTATIC HYPOTENSION (non-serious), outcome "unknown"; THINKING ABNORMAL (non-serious), outcome "unknown", described as "My thinking is not like it should be; not able to think properly". Therapeutic measures were not taken as a result of dyspnoea, asthenia, fatigue, orthostatic hypotension, thinking abnormal. Additional information: When probed for adverse effects, consumer stated, "I get short of breath, weak, tired all the time and my thinking is not like it should be. I have orthostatic hypotension, short of breath and not able to think properly." Prior vaccinations(within 4 weeks): Consumer stated, "No".
Covid symptoms began 2-3 days after shot. Presented to ER day 11 day after positive with extreme dyspnea O2 Sat at 88% Chest xray opacities throughout the bilateral hemithoracies would suggest multifocal infiltrate  Admitted on high flow oxygen reduced to 6 liters currently  D-dimer is >35.20
No adverse event; HCP states that they administered 16 shots to patients after their expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 048L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date).    It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was unknown if patient had any relevant medical history conditions, allergy, concomitant diseases and risk factor. No concomitant medication was reported.  Suspect product dosage text was reported as unknown. The intact cartons of 0.5 ml of were initially stored in the refrigerator and the thaw dates were the same as administration dates as 01-Sep-2022 ,25-Aug-2022, 04-Aug-2022, 26-Jul-2022 and 19-Jul-2022. The vial did not undergo any temperature excursions. No treatment medication was reported. This case is reported for patient 8th out of 16 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-739796 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-739796:Master case
Patient felt chilled and very tired. She started falling asleep while sitting upright. She also became acutely confused and could not identify what year it is, what her phone code was, etc. 911 was notified, but pt felt better about an hour later and did not go to the emergency department for evaluation.
ITCHING ALL OVER, REDNESS, BUMPS FOR APPROX 24 HRS. BENADRYL WAS TAKEN APPROX 30 MIN AFTER VACCINE WAS GIVEN.
Approximately 23 days after administration of HPV 9 in left deltoid patient noted a painful lump at the site of injection. No systemic symptoms. No treatment recommended.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 03/10/21pfizer,Lot#EN6206 2nd dose: 03/31/210,Pfizer,Lot# ER8733 Diagnosed covid positive:0 Symptom onset:07/29/21 Exposure:unknown Symptoms:runny nose, fever
Skin surrounding injection site, approximately 3" diameter - itching, tender, warm, red, inflamed
I was expecting a reaction, since I also had a reaction from the first dose but this time was way worse. For 48 hours I had very intense body aches, chills that would not go away, and off and on sweats. During the first 24 hours, I also experience a bad headache and throwing up. I had no appetite for the 48 hours and bad fatigue.
Rash; Thought it was poison ivy because it is like a blister with water inside; hives; really itchy, all over her face.; arm was sore; blotches on the face; 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 75 year-old female patient received bnt162b2 (COMIRNATY), administration date 19Oct2021 (Batch/Lot number: unknown) at the age of 75 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE: 1), for COVID-19 immunization; Bnt162b2 (DOSE: 2), for COVID-19 immunization. The following information was reported: RASH (non-serious) with onset Oct2021, outcome "unknown", described as "Rash"; BLISTER (non-serious) with onset Oct2021, outcome "unknown", described as "Thought it was poison ivy because it is like a blister with water inside"; URTICARIA (non-serious) with onset Oct2021, outcome "unknown", described as "hives"; PRURITUS (non-serious) with onset Oct2021, outcome "unknown", described as "really itchy, all over her face."; PAIN IN EXTREMITY (non-serious) with onset Oct2021, outcome "unknown", described as "arm was sore"; RASH MACULAR (non-serious) with onset Oct2021, outcome "unknown", described as "blotches on the face". Therapeutic measures were taken as a result of rash, blister, urticaria, pruritus, pain in extremity. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.