Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Oral discomfort, Oral disorder, Pain in extremity, X-ray
Clinical narrative: had arm soreness after each dose was given; diarrhea; real weak; Mouth Burning; break out with bumps around his mouth; Scrotum blood blisters; Severe pain in legs and joints; Second dose: Aches and pains in legs; Second dose: Pain in shoulder; This is a spontaneous report received from a contactable consumer or other non hcp. A male patient of an unspecified age received bnt162b2 (COMINARTY,Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 05Mar2021 as 2ND DOSE, SINGLE for covid-19 immunization .Medical history included ongoing vertigo, ongoing chronic obstructive pulmonary disease Verbatim: COPD, ongoing emphysema , ongoing asthma , cardiac failure congestive from 2018 and ongoing Verbatim: Congestive heart failure , ongoing abdominal discomfort Verbatim: Unspecified stomach problem , pacemaker syndrome from 2020 and ongoing , myocardial infarction from Nov2018 to an unknown date  Verbatim: Heart attack , ongoing gastric bypass Verbatim: Gastric bypass. Concomitant medications included cyanocobalamin (B12) taken for an unspecified indication, start and stop date were not reported. The patient after administration of second dose experienced pain in shoulder (arthralgia) on 05Mar2021 ,aches and pains in legs (pain in extremity)  on 06Mar2021 , had arm soreness after each dose was given (pain in extremity), diarrhea, real weak (asthenia), mouth burning (oral discomfort) , break out with bumps around his mouth (oral disorder) , scrotum blood blisters and severe pain in legs and joints (arthralgia) on an unspecified date.The patient underwent lab tests and procedures which included blood test: nill on Apr2021 ,electrocardiogram: nill  on Apr2021 and x-ray: nill on Apr2021.The outcome of the events pain in shoulder, pain in extremity diarrhea was resolved and oral disorder, blood blister and arthralgia was unknown. Caller reported that he had three vaccine cards and two of the vaccine cards contained one administration and one of the cards contained two administrations.  Caller reported that each of the administrations had a different lot number. Caller stated that he received an injection on 21st Apr2021 but he is unsure whether its covid 19 vaccine or something else. Upon administration of first dose patient had pain in shoulder which started on 2nd feb2021 and lasted half day and gone away. After 2nd dose administration patient had pain on shoulder on 05mar21.Patient stated that he was 75 year old and pain is normal fr him yet after 2nd dose his pain increased. Patient stated that after 3rd dose pain on his shoulder began on 17th apr2021 and lasted 3 days, also patient experienced diarrhea on 22nd or 23rd apr2021. He woked up on 21st apr2021 at night when his dog barked and he was drolled wid sweat. After patient was administered 4th dose he was having sore arm on 21st apr2021.Patient also faced problems with words and problems with body balance on 23rd and 24th apr2021.Caller was unable to provide details for covid 19 vaccine. Caller reported that he had set up an appointment with his physician after he went to the emergency room. Physician asked patient to stop all his medications fr COPD. Patient reported that he had carried out blood test, Ekg and X-rays, The Company Communication: Caller or patient reported that he received 3 doses of the Pfizer Covid-19 vaccine on 02Feb2021, 05Mar2021, and 17Apr2021.  Caller reported that he received a 4th injection on 21Apr2021 that he believes to be a B-12 shot, but he is unsure.  Caller initially reported that he had 3 vaccine cards, one with two administrations listed and two with one administration listed and all with different lot numbers. Attempts was made to clarify whether patient received 3rd and 4th dose of Covid 19 vaccine.  Follow-up #1 (06May2021): This is a follow-up spontaneous report received from a contactable consumer. This 75-year-old male consumer (patient) reported for himself that:Question: Reportum #Caller stated according to the paperwork that he received three shots of covid 19 vaccine at pharmacy and on at the Health facility. Patient stated that he had vertigo for 5 years, he hardly stand up. Patient was admitted to emergency room for 12 hrs at the hospital. Caller states that hospital team said his heart was good, x-rays were good, breathing was good, his pacemaker checks out good. Caller stated that he contacted the DR. office and walgreens but didn't received any response. Caller reports that he had three doses of Pfizer Covid Vaccine. Outbound callback made 06May2021 at 5:14 PM. Caller states he turned 75 y/o on 14Apr2021. Patient received his first dose of the Pfizer Covid vaccine on 02Feb2021, second dose on 05Mar2021, and third dose on 17Apr2021. Patient reported having arm soreness after each dose was given, which resolved but on 24Apr2021 but he developed diarrhea and blisters in his mouth and on his tongue. He states he started to get vertigo soon after that and it is on-going. Patient reported he has pacemaker. The company: will e-transmit as duplicate AE. Response: Referred caller to HCP for treatment recommendations. Spoke from attached document FACT SHEET FOR HCPs ADMINISTERING VACCINE; FULL EUA PI (v1.0) (LAB-1457-7.0 Revised: 06 April 2021) section 6.1.Caller stated that he went to the urologist and according to the paperwork, patient got four shots. Caller states the reactions he's having, he doesn't know if it's normal. Caller stated that he's on the third shot from the vaccine since 02 FEB 2021.Caller verifies all of the shots he received was the Pfizer Covid Vaccine. Caller states they all have different numbers, it's Pfizer, they have different numbers on both the cards. Patient said that he took first covid 19 vaccine dose on 11 feb2021 and lot number was reported as Pfizer 633025-21. and he received in the pharmacy. Caller stated that he received his second shot on 05 MAR 2021 and provides location as LIB Corona 19 Pfizer Vaccine. Caller stated that the next recommended dose was on 26 MAR 2021.Patient received 3rd dose on 17th april 2021 LOT: was reported as Pfizer EW0171 from the pharmacy 002971 from a clinic with health facility. Patient Details: Date of birth: Caller stated on the record it says he was born 14 APR 1947 but his birth certificate mentioned it as 14 APR 1941. Caller states just like over the years his name has been changed to something different. WEIGHT: Caller stated that he was 180 but now he weighs about 163 pounds since 24 APR 2021. Follow-up #2 (06May2021): This is a follow-up spontaneous report received from a contactable consumer. This 80-year-old male consumer (patient) reported for himself that Vertigo: Caller stated that his vertigo started acting up the night of the 24 APR 2021, it's ongoing and it has worsened. Diarrhea: Caller states the diarrhea started about 14 APR 2021 and is ongoing, of and off. Callerstates it has improved because he's been taking some prescription, over the counter medicine. Real Weak: Caller stated that he had been real weak since 14 APR 2021 and it's ongoing, and persisting. The Company Communication: This is a follow-up report. Caller requesting for someone to call him back from the company. Offered to transfer caller to the company and caller declines and would prefer for someone to call him back. Follow-up #3 (06May2021): This is a follow-up spontaneous report received from Pfizer product safety information report form. This report included that: Description of the event, comment, or concern as provided by the reporter: Patient took Covid Vaccine three times. Mouth Burning and break out with bumps around his mouth. Scrotum blood blisters. Severe pain in legs and joints and 1st shot 2/ 2,21, 2nd shot3/ 5/21,3rd shot 4/17/21 possible 4th shot. No follow-up attempts are needed; information about lot/batch number cannot be obtained.